Journal of Pharmaceutical and Biomedical Analysis Open最新文献_第3页

Miniaturization in action: High-resolution, low-cost analytical platforms for biomedical and pharmaceutical research 小型化行动：用于生物医学和药物研究的高分辨率、低成本分析平台

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-12-01 Epub Date: 2025-09-16 DOI: 10.1016/j.jpbao.2025.100089

Erika Maria Ricci , Miryam Perrucci , Marcello Locatelli , Imran Ali , Halil I. Ulusoy , Abuzar Kabir , Fotouh R. Mansour

{"title":"Miniaturization in action: High-resolution, low-cost analytical platforms for biomedical and pharmaceutical research","authors":"Erika Maria Ricci , Miryam Perrucci , Marcello Locatelli , Imran Ali , Halil I. Ulusoy , Abuzar Kabir , Fotouh R. Mansour","doi":"10.1016/j.jpbao.2025.100089","DOIUrl":"10.1016/j.jpbao.2025.100089","url":null,"abstract":"<div><div>Growing concerns over environmental pollution have led to increased emphasis on Green Chemistry and, more specifically, Green Analytical Chemistry (GAC). These frameworks advocate for the reduction of hazardous substances, minimization of waste, and consideration of the entire life cycle of analytical procedures—from production to disposal. Within this context, miniaturized analytical techniques have emerged as sustainable and efficient alternatives to conventional methods. Among these, capillary liquid chromatography (cLC), nano-liquid chromatography (nano-LC), and various modes of capillary electrophoresis (CE)—including micellar electrokinetic chromatography (MEKC), capillary isotachophoresis (CITP), capillary zone electrophoresis (CZE), capillary isoelectric focusing (CIEF), and capillary gel electrophoresis (CGE) have gained significant traction. Their advantages in terms of reduced solvent and sample consumption, enhanced resolution, and faster analysis times have made them particularly valuable in pharmaceutical and biomedical applications. One critical application area is the chiral separation of active pharmaceutical ingredients (APIs), which is increasingly vital in biotechnology, chemistry, agriculture, and especially the pharmaceutical industry. Electrokinetic chromatography (EKC) has proven to be an effective and versatile technique for this purpose, offering high resolution, flexibility, speed, and cost-efficiency. The growing availability of novel chiral selectors further enhances its appeal for the separation of enantiomeric drug compounds. This review provides an overview of recent advancements in miniaturized analytical techniques and highlights their applications in the biomedical and pharmaceutical sectors, with a particular focus on chiral separations using EKC.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100089"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025? 药品中n -亚硝胺风险评估：从监管的角度来看，2025年我们在哪里？

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-12-01 Epub Date: 2025-07-21 DOI: 10.1016/j.jpbao.2025.100084

Yue Zhang, Joëlle Widart, Eric Ziemons, Philippe Hubert, Cédric Hubert

{"title":"N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025?","authors":"Yue Zhang, Joëlle Widart, Eric Ziemons, Philippe Hubert, Cédric Hubert","doi":"10.1016/j.jpbao.2025.100084","DOIUrl":"10.1016/j.jpbao.2025.100084","url":null,"abstract":"<div><div><em>N</em>-nitrosamines have been a concern for decades due to their potential mutagenicity and widespread occurrence across various matrices. While evidence suggests carcinogenicity in animals, their potential carcinogenicity in humans has prompted their initial inclusion in the “cohort of concern” since in ICH M7(R1), and the current ICH M7(R2) guideline is now in effect. Intensified control of <em>N</em>-nitrosamines began in 2018 following the detection of <em>N</em>-nitrosodimethylamine in valsartan-containing products. Subsequent investigations revealed <em>N</em>-nitrosamine contamination across multiple drug classes, triggering widespread recalls, withdrawals, and regulatory actions. Recently, the emergence of <em>N</em>-nitrosamine drug substance-related impurities and drug linker-related impurities has drawn additional regulatory attention. This review presents the methodologies used to determine the acceptable daily intake of <em>N</em>-nitrosamines and traces the evolution of regulatory guidelines, offering a comparative analysis of the 3-step investigation approaches adopted by the European Medicines Agency and Food and Drug Administration. It provides a comprehensive examination of potential root causes for <em>N</em>-nitrosamine contamination, outlines the analytical requirements for confirmatory testing, as well as mitigation strategies to prevent or minimize contamination. Additionally, the review summarizes risk assessment tools used to predict <em>N</em>-nitrosamine formation. By presenting a comprehensive workflow for impurity investigations, this review aims to assist industrial stakeholders in managing <em>N</em>-nitrosamine risks, ensuring regulatory compliance, and safeguarding public health.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100084"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144695369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparative analysis of MS/MS search algorithms in label-free shotgun proteomics for monitoring host-cell proteins using trapped ion mobility and ddaPASEF 利用捕获离子迁移率和ddaPASEF监测宿主细胞蛋白的无标记鸟枪蛋白组学中MS/MS搜索算法的比较分析

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-12-01 Epub Date: 2025-07-21 DOI: 10.1016/j.jpbao.2025.100082

Somar Khalil, Michel Plisnier

{"title":"Comparative analysis of MS/MS search algorithms in label-free shotgun proteomics for monitoring host-cell proteins using trapped ion mobility and ddaPASEF","authors":"Somar Khalil, Michel Plisnier","doi":"10.1016/j.jpbao.2025.100082","DOIUrl":"10.1016/j.jpbao.2025.100082","url":null,"abstract":"<div><div>Host cell proteins (HCPs) are critical quality attributes that can impact the safety, efficacy, and quality of biotherapeutics. Label-free shotgun proteomics is a vital approach for HCP monitoring, yet the choice of tandem mass spectrometry (MS/MS) search algorithms directly influences identification depth and quantification reliability. In this study, six prominent MS/MS search tools (Mascot, MaxQuant, SpectroMine, FragPipe, Byos, and PEAKS) were systematically benchmarked for their performance on complex samples spiked with isotopically labeled proteins from Chinese hamster ovary cells. The data were acquired using trapped ion mobility spectrometry and parallel accumulation–serial fragmentation in data-dependent acquisition mode. Key performance metrics, including peptide and protein identifications, data extraction precision, fold-change (FC) accuracy, linearity, and measurement trueness, were evaluated. A Bayesian modeling framework with Hamiltonian Monte Carlo sampling was employed to robustly estimate FC means and variances, alongside local false discovery rates through posterior probability calibration. Bayesian decision theory, implemented via expected utility maximization, was used to balance accuracy against posterior uncertainty and provide a probabilistic assessment of each tool’s performance. Through this cumulative analysis, variability across tools was observed: Byos and SpectroMine excelled in quantitative accuracy with minimal bias, FragPipe provided high precision and quantifiability, PEAKS offered deep protein coverage, Mascot showed strong trueness, and MaxQuant exhibited moderate identification performance with greater variability at lower spike levels. This study establishes a rigorous, data-driven framework for tool benchmarking and offers guidance for selecting MS/MS tools suited to HCP monitoring in biopharmaceutical development.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100082"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144695366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Nanoplasmonic sensing as a rapid and sensitive methodology to investigate tolvaptan loaded plant-derived nanovesicles and liposomes 纳米等离子体传感作为一种快速、灵敏的方法来研究负载tolvaptan的植物源纳米囊泡和脂质体

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-06-01 Epub Date: 2025-01-06 DOI: 10.1016/j.jpbao.2025.100052

Shishir Jaikishan , Ramila Mammadova , Rui Chen , Feby Pratiwi , Gabriella Pocsfalvi , Seppo J. Vainio , Susanne K. Wiedmer

{"title":"Nanoplasmonic sensing as a rapid and sensitive methodology to investigate tolvaptan loaded plant-derived nanovesicles and liposomes","authors":"Shishir Jaikishan , Ramila Mammadova , Rui Chen , Feby Pratiwi , Gabriella Pocsfalvi , Seppo J. Vainio , Susanne K. Wiedmer","doi":"10.1016/j.jpbao.2025.100052","DOIUrl":"10.1016/j.jpbao.2025.100052","url":null,"abstract":"<div><div>Plant-derived nanovesicles (PDNVs) are potential next generation carriers for drug delivery. However, the systemic incorporation of drugs into PDNVs and their quality control still needs extensive research. Previous works showed that <em>Solanum lycopersicum</em> (tomato) fruit is an excellent resource for the high yield manufacturing of tomato PDNVs. Tomato PDNVs have anti-inflammatory activity <em>in vitro</em> which could be further increased by the loading of a lipophilic natural compound, like curcumin. Recently, tolvaptan, a synthetic selective vasopressin V2-receptor antagonist drug was also successfully loaded into tomato PDNVs. In this work, we have advanced the analysis of native and loaded PDNVs and compared them with liposomes using nanoplasmonic sensing (NPS). Tolvaptan was loaded into liposomes composed of phosphatidyl choline (1-palmitoyl-2-oleoyl-<em>sn</em>-glycero-3-phosphocholine or 1,2-dipalmitoyl-<em>sn</em>-glycero-3-phosphocholine) and 1,2-palmitoyl-oleoyl-<em>sn</em>-glycero-3-phosphoserine with and without cholesterol. In addition to NPS, micro differential scanning calorimetry was used to get a deeper understanding of the interactions between tolvaptan and the various liposome compositions. The result of the comparative NPS study showed that tolvaptan can be successfully incorporated both into PDNVs and liposomes of different compositions. The PDNV/tolvaptan and liposome/tolvaptan systems were found to be stable. Due to the low water solubility of tolvaptan, the developed PDNV/tolvaptan or liposome/tolvaptan nanoparticle complexes may present a novel and effective strategy for nanodrug delivery.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100052"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Is surface-enhanced Raman spectroscopy (SERS) a good alternative to separation techniques for nicotine dosage in e-liquid boosters? 表面增强拉曼光谱（SERS）是电子液体中尼古丁剂量分离技术的一个很好的替代方法吗？

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-06-01 Epub Date: 2025-01-16 DOI: 10.1016/j.jpbao.2025.100054

Charlotte De Bleye , Pierre Beckers , Kevser Kemik , Julie Horne , Kenza Lahrichi , Pierre-Yves Sacré , Philippe Hubert , Eric Ziemons

{"title":"Is surface-enhanced Raman spectroscopy (SERS) a good alternative to separation techniques for nicotine dosage in e-liquid boosters?","authors":"Charlotte De Bleye , Pierre Beckers , Kevser Kemik , Julie Horne , Kenza Lahrichi , Pierre-Yves Sacré , Philippe Hubert , Eric Ziemons","doi":"10.1016/j.jpbao.2025.100054","DOIUrl":"10.1016/j.jpbao.2025.100054","url":null,"abstract":"<div><div>Since 2014, electronic cigarettes must follow the European Directive on tobacco products. In Belgium, the transposition of this directive requires that nicotine-containing e-liquid boosters cannot exceed a concentration of 20 mg mL<sup>−1</sup> to ensure consumers safety. Nowadays, accurate analytical methods available to measure nicotine levels in e-liquid products involve chromatography. The development of alternative analytical tools being faster, greener and adaptable to in-field analyses are therefore required. Surface-enhanced Raman scattering is a spectroscopic technique that significantly enhances inherent Raman scattering signals, improving detection limits, when analytes are adsorbed onto metallic nanostructures such as gold nanoparticles (AuNPs). This study introduces new SERS methods for quantifying nicotine in e-liquid boosters using two different Raman spectrophotometers based on a transmission (SETRS) and a backscattering detection mode. The transmission Raman spectrophotometer has a better sample representativity, which is very interesting to perform SERS on liquids samples, and an autosampler offering facilities for routine analyses as a benchtop equipment while the second spectrophotometer was a handheld Raman device allowing to expand the use of the developed SERS method to in-field analyses. These SERS analyses were performed using lab-synthetized AuNps and by adding an isotope-edited internal standards (IEISs) being nicotine-d4 to mitigate some repeatability issues. These methods were finally validated according to the ICH Q2 (R2) guidelines for a working range from 100 to 300 µg L<sup>−1</sup> of nicotine concentrations using a total error risk-based approach considering the acceptance limits fixed at 15 % and a risk level of 5 %.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100054"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A compendium of noncoding RNAs as biomarkers in Type 2 Diabetes Mellitus 非编码rna作为2型糖尿病生物标志物的综述

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-06-01 Epub Date: 2025-01-30 DOI: 10.1016/j.jpbao.2025.100057

Manjusha Sita Akella, Angel Mendonca, Thanikes Manikandan, Dhananjay Sateesh, Akshitha Rajesh Swaminathan, Disha Parameshwaran, Manishika Gupta, Sujatha Sundaresan

{"title":"A compendium of noncoding RNAs as biomarkers in Type 2 Diabetes Mellitus","authors":"Manjusha Sita Akella, Angel Mendonca, Thanikes Manikandan, Dhananjay Sateesh, Akshitha Rajesh Swaminathan, Disha Parameshwaran, Manishika Gupta, Sujatha Sundaresan","doi":"10.1016/j.jpbao.2025.100057","DOIUrl":"10.1016/j.jpbao.2025.100057","url":null,"abstract":"<div><div>Diabetes Mellitus (DM) is among the most widespread multifactorial disorders worldwide, defined by increased plasma glucose levels. Type 2 Diabetes Mellitus (T2DM) is the most prevalent and common form of diabetes mellitus. T2DM is a metabolic condition characterized by abnormal blood glucose levels, insulin resistance in target tissues, and a reduced mass and function of islet β cells. Highlighting the significance of investigating new biomarkers, particularly during the initial stages of development, noncoding RNAs (ncRNAs) have been identified as valuable resources for T2DM. NcRNAs are a class of RNAs found in humans that play significant roles in epigenetics and in regulating post-transcriptional gene expression. Since they function as regulatory molecules, upon base pairing with the mRNA, they exhibit post-transcriptional alterations in the signaling cascade within the cells by regulating the expression of multiple targets simultaneously. Small non-coding RNAs (sncRNAs) and long non-coding RNAs (lncRNAs) are the two primary categories of non-coding RNAs. Several studies have shown that sncRNAs and lncRNAs have evolved as potential biomarkers in T2DM. This review focuses on non-coding RNAs as biomarkers for T2DM and their role in preventing chronic complications.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100057"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143280732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Innovative QSRR modeling approach for the development of an ultra-sensitive LC-MS/MS method for trace analysis of N-nitrosamines 创新的QSRR建模方法用于开发n -亚硝胺痕量分析的超灵敏LC-MS/MS方法

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-06-01 Epub Date: 2025-02-19 DOI: 10.1016/j.jpbao.2025.100064

Yue Zhang, Sabah Houari, Thomas Van Laethem, Amandine Dispas, Eric Ziemons, Philippe Hubert, Cédric Hubert

{"title":"Innovative QSRR modeling approach for the development of an ultra-sensitive LC-MS/MS method for trace analysis of N-nitrosamines","authors":"Yue Zhang, Sabah Houari, Thomas Van Laethem, Amandine Dispas, Eric Ziemons, Philippe Hubert, Cédric Hubert","doi":"10.1016/j.jpbao.2025.100064","DOIUrl":"10.1016/j.jpbao.2025.100064","url":null,"abstract":"<div><div>To address regulatory concerns regarding N-nitrosamine contamination in pharmaceutical products, generic LC-MS/MS methods for determining N-nitrosamines were developed using an innovative <em>in silico</em> approach based on Quantitative Structure Retention Relationship modeling (QSRR). The development process included screening and optimization phases, offering flexibility in targeting N-nitrosamines and addressing the challenges related to the matrix effect. This methodology represents a significant advancement in method development. Among the developed methods, a highly sensitive and accurate LC-MS/MS method was successfully validated to simultaneously determine 5 small-molecule N-nitrosamine impurities in tablets, which was used in the present proof-of-concept study. The validation followed the ICH Q2 (R2) guidelines, employing a combined approach for accuracy and precision based on total error risk-based methodology. The method was validated to function as both an impurity limit test and a quantitative method. Validation results demonstrated adequate quantitative performance of the method, establishing a validated dosing range from 1 to 30 ng/mL for all N-nitrosamines. The estimated detection limit ranged from 0.75 pg/mL to 0.02 ng/mL. The detection and quantification limits for each N-nitrosamine met the EMA N-nitrosamine investigation approach requirements. Moreover, both are always below 10 % of their respective acceptable limit in the studied finished product formulation. This proposed method is suitable for investigating small-molecule N-nitrosamines in pharmaceutical products and also provides a starting point for further method development, particularly for the determination of newly identified small-molecule N-nitrosamines and drug-substance-related N-nitrosamines.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100064"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143445617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Laser-induced graphene electrodes obtained by direct laser writing for pharmaceutical and biomedical analysis 激光诱导石墨烯电极，直接激光写入，用于制药和生物医学分析

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-06-01 Epub Date: 2025-03-01 DOI: 10.1016/j.jpbao.2025.100069

Amal Rabti , Sabrine Baachaoui , Mohamed Zouari , Noureddine Raouafi

{"title":"Laser-induced graphene electrodes obtained by direct laser writing for pharmaceutical and biomedical analysis","authors":"Amal Rabti , Sabrine Baachaoui , Mohamed Zouari , Noureddine Raouafi","doi":"10.1016/j.jpbao.2025.100069","DOIUrl":"10.1016/j.jpbao.2025.100069","url":null,"abstract":"<div><div>Laser-induced graphene (LIG), also referred to as laser-ablated graphene (LAG), laser-scribed graphene (LSG), laser-produced graphene (LPG), laser-engineered graphene (LEG), and laser-derived graphene (LDG), has emerged as a versatile material for the development of high-performance electrodes that exhibit unique properties, such as high electrical conductivity, large surface area, chemical stability, and ease of functionalization. These characteristics render LIG electrodes particularly suitable for pharmaceutical and biomedical applications where rapid, sensitive, and reliable analytical methods are required. This review presents a comprehensive overview of recent advancements in the utilization of graphene electrodes for pharmaceutical and biomedical applications. They encompass their fabrication processes, surface modifications with nanomaterials and biomolecules, and the principal analytical techniques employed, including electrochemical sensing, biosensing, and drug monitoring. Particular emphasis is placed on the integration of LIG electrodes into point-of-care devices for clinical diagnostics and therapeutic drug monitoring, as well as their role in detecting biomarkers and pharmaceutical residues. Furthermore, the challenges and future perspectives for LIG electrodes in achieving widespread adoption in the biomedical and pharmaceutical fields are examined, underscoring the need for improved scalability, selectivity, and regulatory compliance. This review elucidates the transformative potential of LIG-based technologies for addressing emerging healthcare challenges through innovative and cost-effective analytical solutions.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100069"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143548765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of a new green gas chromatographic method for the determination of zolmitriptan in pure and pharmaceutical preparations 建立一种新的绿色气相色谱法测定纯制剂和制剂中唑米曲坦的含量

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-06-01 Epub Date: 2025-01-30 DOI: 10.1016/j.jpbao.2025.100059

Reem Hasan Obaydo R.H.Obaydo , Abdulsalam Ashkar , Raneem Khayyat , Salem Alhamdan , Hadeel Kallas , Mohammad Kharrat , Amir Alhaj Sakur

{"title":"Development of a new green gas chromatographic method for the determination of zolmitriptan in pure and pharmaceutical preparations","authors":"Reem Hasan Obaydo R.H.Obaydo , Abdulsalam Ashkar , Raneem Khayyat , Salem Alhamdan , Hadeel Kallas , Mohammad Kharrat , Amir Alhaj Sakur","doi":"10.1016/j.jpbao.2025.100059","DOIUrl":"10.1016/j.jpbao.2025.100059","url":null,"abstract":"<div><div>A simple, accurate, and environmentally friendly method for determining raw zolmitriptan (ZMT) and its dosage form (tablets) was developed and validated using capillary gas chromatography (GC). Methanol was used to prepare the solutions of the standard and the sample, and instrument parameters were optimized with a programmed temperature ramp ranging from 230 to 290 °C, achieving a total run time of 9.0 min. The retention times for Metronidazole Benzoate (MNZB), the internal standard, and ZMT were found to be 4.89 and 8.11 min, respectively. GC separation was performed with a TRB-5 capillary column (30 m × 0.25 mm, 0.25 μm) with a 0.5 μL injection in splitless mode. The calibration curve was linear when testing a range of concentrations of 6.0–80.0 μg/mL. The limits of detection (LOD) and quantification (LOQ) were determined to be 0.53 and 1.77 μg/mL, respectively, with a correlation coefficient (R²) greater than 0.999. The method proposed was efficiently applicable to analyze pure ZMT and in tablets, showing no interference from other components of the pharmaceutical preparation. Validation of the method was done per ICH guidelines, with all parameters meeting the required acceptance criteria. Additionally, evaluation of the greenness and sustainability of the GC method proposed was performed using AGREE, modified GAPI, and the RGB fast model.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100059"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143280731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Nanohybrids based on multi-walled carbon nanotubes and MOF-199: Advantages on the electrochemical reduction of hydrogen peroxide and sensing applications 基于多壁碳纳米管和MOF-199的纳米杂化材料：过氧化氢电化学还原及传感应用的优势

Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-06-01 Epub Date: 2025-02-18 DOI: 10.1016/j.jpbao.2025.100066

Pablo A. Gallay , Virginia M. Vaschetti , Facundo Aghemo , Pablo R. Dalmasso , Gustavo A. Rivas

{"title":"Nanohybrids based on multi-walled carbon nanotubes and MOF-199: Advantages on the electrochemical reduction of hydrogen peroxide and sensing applications","authors":"Pablo A. Gallay , Virginia M. Vaschetti , Facundo Aghemo , Pablo R. Dalmasso , Gustavo A. Rivas","doi":"10.1016/j.jpbao.2025.100066","DOIUrl":"10.1016/j.jpbao.2025.100066","url":null,"abstract":"<div><div>We report the advantages of a nanohybrid obtained through the integration of multi-walled carbon nanotubes (MWCNTs) and MOF-199 by sono-synthesis. The resulting nanohybrid presents important synergic effects on the catalytic reduction of hydrogen peroxide due to the facilitated regeneration of the catalytic center in the presence of the interconnected carbon nanomaterial. Glassy carbon electrodes (GCE) modified with this hybrid nanomaterial dispersed in Nafion allowed the sensitive quantification of hydrogen peroxide: linear range between 5.0 × 10<sup>−6</sup> M and 7.5 × 10<sup>−5</sup> M (R<sup>2</sup> = 0.997), with a sensitivity of (128 ± 3) x 10<sup>2</sup> µA M<sup>−1</sup>, a detection limit of 2 µM, and a reproducibility of 8.0 % for the same nanohybrid and 5 different electrodes allowing the competitive electrochemical determination of hydrogen peroxide. The sensor was successfully used for the quantification of this important analyte in diverse commercial samples (milk, human serum, contact lens disinfecting solution, and mouthwash).</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100066"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0