Journal of Pharmaceutical and Biomedical Analysis Open最新文献

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Design of experiments-assisted UPLC method for quantification of nitrosamine impurities in glimepiride and lobeglitazone sulfate: A green chemistry approach 格列美脲和硫酸洛贝列酮亚硝胺杂质定量的实验辅助超高效液相色谱法设计:绿色化学方法
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-05-05 DOI: 10.1016/j.jpbao.2025.100078
KiranKumar Chagarlamudi , Venkata Kanaka Srivani Maddala , Kumaraswamy Gandla
{"title":"Design of experiments-assisted UPLC method for quantification of nitrosamine impurities in glimepiride and lobeglitazone sulfate: A green chemistry approach","authors":"KiranKumar Chagarlamudi ,&nbsp;Venkata Kanaka Srivani Maddala ,&nbsp;Kumaraswamy Gandla","doi":"10.1016/j.jpbao.2025.100078","DOIUrl":"10.1016/j.jpbao.2025.100078","url":null,"abstract":"<div><div>A robust ultra-performance liquid chromatography (UPLC) method was developed and systematically optimized using a Design of Experiments (DoE) approach for the simultaneous quantification of glimepiride, lobeglitazone sulfate, nitrosamine impurity-3 (IMP-3), and impurity-1 (IMP-1) in the marketed LOBG-G1 formulation. Critical method parameters, including organic phase composition, flow rate, and mobile phase pH, were identified through a comprehensive risk assessment and subsequently optimized using a Box-Behnken design. The final chromatographic conditions—50 % organic phase composition, a flow rate of 0.2 mL/min, and a mobile phase pH of 2.6—ensured efficient separation and quantification of all four analytes. The method was validated in accordance with ICH guidelines, demonstrating excellent linearity (r² &gt; 0.999), high accuracy, and precision, with low relative standard deviation values. Stability studies conducted under different stress conditions revealed significant degradation of all four compounds in acidic, alkaline, and oxidative environments. Degradation products were further characterized using LC-MS/MS analysis, confirming their structural identity. In addition to its analytical performance, the method's environmental sustainability was evaluated using multiple green analytical chemistry assessment tools. The DoE-guided UPLC method offers a highly sensitive, selective, and reproducible analytical platform for the detection of nitrosamine impurities in antidiabetic drugs, providing enhanced method understanding while aligning with sustainability principles.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100078"},"PeriodicalIF":0.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143907640","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
Advancing biomedical analysis: Harnessing laser-induced graphene for next-gen of low-cost sensor technology 推进生物医学分析:利用激光诱导石墨烯用于下一代低成本传感器技术
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-04-26 DOI: 10.1016/j.jpbao.2025.100077
Elsa Maria Materón , Liana Melo Lins de Azevedo , Juliana Martins Dias , Ketley Caroline Rocha Pereira , Gustavo Miguel Sousa , Matheus Santos Dias , Camila Marchetti Maroneze , Daiane Dias , Cecilia de Carvalho Castro Silva
{"title":"Advancing biomedical analysis: Harnessing laser-induced graphene for next-gen of low-cost sensor technology","authors":"Elsa Maria Materón ,&nbsp;Liana Melo Lins de Azevedo ,&nbsp;Juliana Martins Dias ,&nbsp;Ketley Caroline Rocha Pereira ,&nbsp;Gustavo Miguel Sousa ,&nbsp;Matheus Santos Dias ,&nbsp;Camila Marchetti Maroneze ,&nbsp;Daiane Dias ,&nbsp;Cecilia de Carvalho Castro Silva","doi":"10.1016/j.jpbao.2025.100077","DOIUrl":"10.1016/j.jpbao.2025.100077","url":null,"abstract":"<div><div>As biosensors and biomedical devices gain increasing importance in everyday diagnostics and health status monitoring, the need to develop and improve their reliability and versatility becomes more pronounced. In this context, the search for new materials for biosensors and biomedical devices has intensified, leading to the emergence of laser-induced graphene (LIG) as a promising candidate. LIG's environmentally sustainable nature, cost-effectiveness, and significant potential for large-scale graphene production and directed writing electronics circuits make it very interesting. In this review, we provide an overview of the mechanisms and precursor materials involved in LIG production, strategies to enhance graphene properties through the <em>in-situ</em> generation of hybrid materials via direct laser writing, and the crucial role of LIG in the development of cost-effective, point-of-care, and wearable devices for medical diagnosis and real-time health status monitoring.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100077"},"PeriodicalIF":0.0,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143882125","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
Determination of rapid and sensitive extraction of colchicine from Colchicum baytopiorum and Colchicum decaisnei leaves by HPLC-UV method 高效液相色谱-紫外分光光度法测定秋水仙叶和秋水仙叶中秋水仙碱的快速灵敏提取
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-04-22 DOI: 10.1016/j.jpbao.2025.100076
Efe Deniz , Ümit Babacan , Ceren Selim , Mehmet Fatih Cengiz
{"title":"Determination of rapid and sensitive extraction of colchicine from Colchicum baytopiorum and Colchicum decaisnei leaves by HPLC-UV method","authors":"Efe Deniz ,&nbsp;Ümit Babacan ,&nbsp;Ceren Selim ,&nbsp;Mehmet Fatih Cengiz","doi":"10.1016/j.jpbao.2025.100076","DOIUrl":"10.1016/j.jpbao.2025.100076","url":null,"abstract":"<div><div>This study focuses on the extraction and analysis of colchicine, a bioactive alkaloid, from the leaves of two endemic species, <em>Colchicum baytopiorum</em> (n = 13) and <em>Colchicum decaisnei</em> (n = 11), collected from Antalya, Türkiye. Colchicine, known for its pharmacological applications for the treatment of gout and cancer, was extracted using ultrasonic-assisted extraction, a more environmentally friendly alternative to conventional methods like Soxhlet and solid-liquid extraction. High-performance liquid chromatography was used for the quantification of colchicine levels in the plant samples. The method was validated in terms of linear dynamic range, limit of detection (LOD), limit of quantification (LOQ) and relative standard deviation (RSD). Results showed that LOD, LOQ and RSD values were determined to be 0.210 ppm, 0.799 ppm and 1.420, respectively. <em>C. baytopiorum</em> had a higher colchicine content (206.24 ± 87.48 ppm) compared to <em>C. decaisnei</em> (11.23 ± 23.04 ppm). These findings are consistent with previous studies, which report varying colchicine concentrations across different Colchicum species. The study suggests that genetic research could help identify the specific genes responsible for colchicine production, which could enhance its availability in pharmaceutical applications. This research contributes to understanding colchicine extraction and its potential for medical use.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100076"},"PeriodicalIF":0.0,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143870439","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
Magnetic solid-phase extraction of Sudan dyes from beverages-coated magnetite/silica materials 饮料包覆磁铁矿/二氧化硅材料中苏丹红染料的磁固相萃取
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-03-12 DOI: 10.1016/j.jpbao.2025.100073
Yugao Guo , Xiaoxiao Niu , Boyu Li , Pei Liu , Youqing Sun , Sumin Lu
{"title":"Magnetic solid-phase extraction of Sudan dyes from beverages-coated magnetite/silica materials","authors":"Yugao Guo ,&nbsp;Xiaoxiao Niu ,&nbsp;Boyu Li ,&nbsp;Pei Liu ,&nbsp;Youqing Sun ,&nbsp;Sumin Lu","doi":"10.1016/j.jpbao.2025.100073","DOIUrl":"10.1016/j.jpbao.2025.100073","url":null,"abstract":"<div><div>In this study, a polydopamine-coated magnetite/silica composite material (Fe<sub>3</sub>O<sub>4</sub>@SiO<sub>2</sub>/PDA) was successfully synthesized and characterized using Fourier-transform infrared spectroscopy (FT-IR), X-ray diffraction (XRD), and X-ray photoelectron spectroscopy (XPS). By integrating EM-MSPE with high-performance liquid chromatography (HPLC), a novel EM-MSPE-HPLC method was established for the sensitive and accurate determination of Sudan I-IV dyes. Key experimental parameters, such as adsorbent dosage, pH, inorganic salt concentration, adsorption time, voltage, eluent type, eluent volume, and desorption time, were systematically investigated and optimized. Under optimal conditions, the method demonstrated excellent linearity (R² &gt; 0.999) within a concentration range of 5–1000 μg L⁻¹, with limits of detection (LODs) ranging from 0.11 to 0.17 μg L⁻¹. The recoveries of Sudan dyes in real samples ranged from 89.1 % to 101.9 %, with relative standard deviations (RSDs) between 0.3 % and 3.6 %. Furthermore, the Fe<sub>3</sub>O<sub>4</sub>@SiO<sub>2</sub>/PDA adsorbent exhibited consistent performance over ten consecutive extraction cycles without significant loss in recovery efficiency. These findings demonstrate that the proposed method is accurate, reliable, and reproducible for the simultaneous determination of Sudan dyes in complex beverage matrices, offering a robust analytical approach for food safety applications.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100073"},"PeriodicalIF":0.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143686909","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
Direct sample introduction in high-performance liquid chromatography analysis of oily medicinal cannabis samples using surfactant-free microemulsion 使用无表面活性剂微乳液对含油药用大麻样品进行高效液相色谱分析,直接进样
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-03-11 DOI: 10.1016/j.jpbao.2025.100075
Ana Paula Lamounier, Bárbara da Conceição Coelho Cotta Cardoso, Alessandra Licursi Maia Cerqueira da Cunha
{"title":"Direct sample introduction in high-performance liquid chromatography analysis of oily medicinal cannabis samples using surfactant-free microemulsion","authors":"Ana Paula Lamounier,&nbsp;Bárbara da Conceição Coelho Cotta Cardoso,&nbsp;Alessandra Licursi Maia Cerqueira da Cunha","doi":"10.1016/j.jpbao.2025.100075","DOIUrl":"10.1016/j.jpbao.2025.100075","url":null,"abstract":"<div><div>The therapeutic use of medicinal Cannabis has raised challenges in quality control and cannabinoid quantification in oil extracts, primarily due to incompatibility with liquid chromatography systems. Surfactant-free microemulsion (SFME) systems offer a promising, efficient, and sustainable solution, enabling direct analysis by high-performance liquid chromatography. These microemulsions are dispersions of two immiscible liquids, typically oil and water, made compatible by an amphiphilic substance that interacts with both polar and nonpolar fractions. After SFME testing and critical analysis of the results, clear and homogeneous microemulsions were observed regardless of the oil-to-water ratio studied, provided that sufficient quantities of 1-octanol:1-propanol (3:10 v/v) were added. Based on the established robust working range, the 1:2 (oil:ultrapure water) ratio (% w/w) was chosen as the compromise condition, minimizing medicinal oil use while ensuring compatibility with the chromatographic system. Univariate optimization of chromatographic conditions enabled simultaneous analysis of five cannabinoids, including cannabidiol (CBD), cannabidiolic acid (CBDA), tetrahydrocannabutol (THCB), cannabinol (CBN), and tetrahydrocannabinol (Δ9-THC) using a ZORBAX Eclipse Plus C18 column at 35 °C. The method employed isocratic elution with a mobile phase of 82:18 %v/v methanol:ultrapure water containing 0.15 ± 0.05 % v/v formic acid, a 1.0 mL min<sup>−1</sup> flow rate, and a 20 μL injection volume, using the fluorescence and UV absorption detectors. This proposal offers sensitivity (LOD in the ng mL<sup>−1</sup>), selectivity, and separation efficiency, associated with low cost, minimal waste generation, and low energy demand, aligning with Green Chemistry principles.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100075"},"PeriodicalIF":0.0,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143644376","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
Interstitial fluid-based optical biosensors 基于间隙流体的光学生物传感器
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-03-10 DOI: 10.1016/j.jpbao.2025.100074
Atefeh Rahimzadeh , Abrisham Arjomandkhah , Mohammad Ali Kiani, Hamed Golmohammadi
{"title":"Interstitial fluid-based optical biosensors","authors":"Atefeh Rahimzadeh ,&nbsp;Abrisham Arjomandkhah ,&nbsp;Mohammad Ali Kiani,&nbsp;Hamed Golmohammadi","doi":"10.1016/j.jpbao.2025.100074","DOIUrl":"10.1016/j.jpbao.2025.100074","url":null,"abstract":"<div><div>The high reproducibility and reliability of optical biosensors, alongside the extraordinarily features of interstitial fluid (ISF) as a promising biological fluid with blood-like composition and yet noninvasive or minimally invasive sampling, have led to the development of a variety of the ISF-based optical biosensors for diagnostic and health monitoring applications. In the present review, while introducing ISF, its characteristics, and the methods developed for its sampling, various types of optical biosensors developed so far for the colorimetric, fluorometric, and surface-enhanced Raman spectroscopy determination of (bio)chemical compounds in ISF are reviewed. Lastly, future prospects and views on the main challenges facing the further development of ISF-based optical biosensors are delineated. Building upon the extraordinary features of ISF-based optical biosensors as highly promising and potential biosensors, we anticipate that they will be greatly welcomed and many of the existing blood-based optical biosensors will be replaced by ISF-based ones in the near future.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100074"},"PeriodicalIF":0.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143642253","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
How does HSA's antioxidant activity change under the influence of lincomycin and spectinomycin mixture? – A spectroscopic study 林可霉素与大观霉素混合作用对HSA的抗氧化活性有何影响?-光谱研究
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-03-08 DOI: 10.1016/j.jpbao.2025.100070
Wojciech Rogóż, Aleksandra Owczarzy, Karolina Kulig, Małgorzata Maciążek-Jurczyk
{"title":"How does HSA's antioxidant activity change under the influence of lincomycin and spectinomycin mixture? – A spectroscopic study","authors":"Wojciech Rogóż,&nbsp;Aleksandra Owczarzy,&nbsp;Karolina Kulig,&nbsp;Małgorzata Maciążek-Jurczyk","doi":"10.1016/j.jpbao.2025.100070","DOIUrl":"10.1016/j.jpbao.2025.100070","url":null,"abstract":"<div><div>Lincomycin (LIN) belongs to the lincosamides group and is used in bacterial infections of soft tissues, the respiratory system, bone marrow, and bones, while spectinomycin (SPE) belongs to the group of aminoglycoside antibiotics and is used for the treatment of gonorrhoea. Both antibiotics are commonly used to treat humans separately while their mixture is used in veterinary preparations (SPE-LIN), and the combination of these antibiotics has not yet been used for human treatment. The aim of this study was to search for modulators of human serum albumin (HSA) antioxidant activity among antibacterial drugs, lincomycin (LIN) and spectinomycin (SPE). In order to study the effect of LIN and SPE on HSA antioxidant properties the DPPH and ABTS tests were used. UV-Vis spectrophotometry and circular dichroism (CD) spectroscopic techniques were used to find the cause of LIN and SPE modulatory activity related to HSA antiradical potential. Both LIN and SPE, as well as their mixture, did not show significant antioxidant activity, while in combination with HSA, they stimulated its antioxidant properties. CD measurements determined that the dominant secondary structure of HSA, regardless of the presence of ligands, was α-helix, and its percentage share slightly increased under the influence of LIN and SPE. The obtained results confirm the viability of further studies on the potential application of the combination of SPE-LIN in the treatment, not only in breeding animals. The proposed concept of research may be a response to the future needs in medicine. The assumed goal, which was the search for HSA modulators, has been achieved.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100070"},"PeriodicalIF":0.0,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143601102","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
“Quartz crystal microbalance-based biosensor for rapid and ultrasensitive SARS-CoV-2 detection" 用于快速超灵敏检测SARS-CoV-2的石英晶体微天平生物传感器
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-03-07 DOI: 10.1016/j.jpbao.2025.100071
Sahera Saleh , Habib Alkalamouni , Karen Antar , Joe Rahme , Michel Kazan , Pierre Karam , Jit Muthuswamy , Hassan Zaraket , Massoud L. Khraiche
{"title":"“Quartz crystal microbalance-based biosensor for rapid and ultrasensitive SARS-CoV-2 detection\"","authors":"Sahera Saleh ,&nbsp;Habib Alkalamouni ,&nbsp;Karen Antar ,&nbsp;Joe Rahme ,&nbsp;Michel Kazan ,&nbsp;Pierre Karam ,&nbsp;Jit Muthuswamy ,&nbsp;Hassan Zaraket ,&nbsp;Massoud L. Khraiche","doi":"10.1016/j.jpbao.2025.100071","DOIUrl":"10.1016/j.jpbao.2025.100071","url":null,"abstract":"<div><div>The COVID-19 pandemic highlighted the urgent need for rapid, sensitive, and affordable diagnostic tests, especially in resource-limited settings. While RT-qPCR remains the gold standard for SARS-CoV-2 detection, it is expensive and requires specialized equipment. Antigen-based tests, though faster, lack sufficient sensitivity. Therefore, there is a pressing need for a platform that combines the rapidity of antigen tests with the sensitivity of molecular tests. In this work, we address this problem by developing a Quartz Crystal Microbalance (QCM) biosensor for the rapid detection of SARS-CoV-2 nucleocapsid proteins. We designed a QCM biosensor with polyethylene glycol (PEG)-based surface functionalization, which significantly improves sensitivity and specificity. The platform achieved a detection limit of 53.3 TCID<sub>50</sub>/mL and a sensitivity of 0.263 Hz/ TCID<sub>50</sub>/mL, with results available in approximately 15 min. Cross-reactivity tests with Influenza A demonstrated its high specificity for SARS-CoV-2. Comprehensive surface characterization using Scanning Electron Microscopy (SEM), Digital Holographic Microscopy, and Raman Spectroscopy confirmed the stability and integrity of the functionalized sensor surface. The platform is cost-effective, scalable, and designed for ease of use in resource-limited settings. This work presents the first open-source QCM biosensing platform for SARS-CoV-2 detection that combines high sensitivity, rapid results, and affordability. It offers a deployable solution for COVID-19 diagnostics, particularly in underserved regions, and is adaptable for future pandemic preparedness.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100071"},"PeriodicalIF":0.0,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143686908","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
Therapeutic siRNA quantification in lipid nanoparticles using ion-pair reversed-phase chromatography 使用离子对反相色谱法定量脂质纳米颗粒中的治疗性siRNA
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-03-03 DOI: 10.1016/j.jpbao.2025.100072
Ludivine Ferey, Sandy Al Bardawil, Emilie Dols, Aurore Guédin, Viet-Ha Phan, Philippe Barthélémy, Jeanne Leblond Chain
{"title":"Therapeutic siRNA quantification in lipid nanoparticles using ion-pair reversed-phase chromatography","authors":"Ludivine Ferey,&nbsp;Sandy Al Bardawil,&nbsp;Emilie Dols,&nbsp;Aurore Guédin,&nbsp;Viet-Ha Phan,&nbsp;Philippe Barthélémy,&nbsp;Jeanne Leblond Chain","doi":"10.1016/j.jpbao.2025.100072","DOIUrl":"10.1016/j.jpbao.2025.100072","url":null,"abstract":"<div><div>The clinical development of lipid nanoparticles encapsulating small interfering RNA (siRNA-LNP) requires robust and efficient analytical methods for quality assessment. In this study, we investigated the chromatographic profiles of siRNAs using Ion-Pair Reversed-Phase (IP-RP) HPLC at six different temperatures, including the melting temperature of duplexes, on two RP columns. The column temperature was identified as a critical parameter influencing chromatographic profiles, with characteristic profiles evolving in a temperature-dependent manner, corresponding to the melting temperatures (T<sub>m</sub>) of the two siRNA duplexes analyzed, across both tested columns. Moreover, the siRNA dissociation observed on the columns was consistent with the melting temperatures of the duplexes measured by UV-Vis spectroscopy under HPLC mobile phase conditions. An IP-RPHPLC method using 100 mM TEAA with ACN and a column temperature of 80 °C, above the T<sub>m</sub> of the analyzed duplexes, was successfully applied for the quantitative determination of siRNAs in LNP formulations. A simple, one-step sample preparation was employed by directly adding a neutral surfactant to the LNP samples before injection. This method proved highly accurate, as shown by a 100 % recovery of siRNA immediately following microfluidic formulation. Additionally, the impact of the dialysis purification process on siRNA recovery was assessed, revealing a 30 % loss of siRNA. Importantly, the results obtained from this method were consistent with those from the fluorescence reference method. This method helps improve the quality control of siRNA-LNP therapeutics, thereby enhancing their clinical translation potential and supporting the development of next-generation RNA-based therapies.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100072"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143593207","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 : 2025-03-01 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 ,&nbsp;Sabrine Baachaoui ,&nbsp;Mohamed Zouari ,&nbsp;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":"2025-03-01","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
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