Biomedical Chromatography最新文献_第2页

A Simple and Rapid HPLC Method Development for Quantification of Sodium Benzoate Content in Chlorzoxazone Oral Solid Dosage Forms 一种用于定量氯唑沙宗口服固体制剂中苯甲酸钠含量的简便快速高效液相色谱法的开发

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-19 DOI: 10.1002/bmc.6048

Prasanna Kumar Lankalapalli, Teja Kamireddy, Pranitha Sambu

{"title":"A Simple and Rapid HPLC Method Development for Quantification of Sodium Benzoate Content in Chlorzoxazone Oral Solid Dosage Forms","authors":"Prasanna Kumar Lankalapalli, Teja Kamireddy, Pranitha Sambu","doi":"10.1002/bmc.6048","DOIUrl":"10.1002/bmc.6048","url":null,"abstract":"<div>\u0000 \u0000 <p>The present study discusses the development of a simple, rapid, and specific HPLC method for the estimation of sodium benzoate in chlorzoxazone tablet dosage formulations. The current developed HPLC method was validated as per the current ICH guidelines. The chromatographic separation was achieved using a 0.02-M phosphate buffer adjusted to pH 3.0 with orthophosphoric acid as the buffer. Mobile phase A consisted of 100% buffer, and mobile phase B was a mixture of acetonitrile and buffer in a ratio of 80:20 (v/v). The column temperature was maintained at 30°C, the sample cooler at 25°C, and the flowrate at 0.8 mL min<sup>−1</sup>. The injection volume was 10 μL. The UV detection was performed at 230 nm for Sodium benzoate. The validated HPLC method was highly specific, with linearity ranging between 1.2 and 7.5 μg/mL for sodium benzoate, and the correlation coefficient was found to be > 0.999. The method showed high accuracy, exceeding 97%. The results demonstrate the successful applicability of the current method for the estimation of sodium benzoate in marketed formulations, which can be extended to assess other formulation systems. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, precision, accuracy, and robustness. The method was applied to the analysis of stability samples.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development and Validation of a Headspace GC–MS Method for Simultaneous Quantification of Antimicrobial Preservatives in Biopharmaceutical Peptide Formulations 开发并验证用于同时定量生物制药多肽制剂中抗菌防腐剂的顶空 GC-MS 方法。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-19 DOI: 10.1002/bmc.6045

Susan Daniela Selaya, Nicolas Abrigo, Clark Jones, Maxwell Korang-Yeboah, Patrick J. Faustino, Diaa Shakleya

{"title":"Development and Validation of a Headspace GC–MS Method for Simultaneous Quantification of Antimicrobial Preservatives in Biopharmaceutical Peptide Formulations","authors":"Susan Daniela Selaya, Nicolas Abrigo, Clark Jones, Maxwell Korang-Yeboah, Patrick J. Faustino, Diaa Shakleya","doi":"10.1002/bmc.6045","DOIUrl":"10.1002/bmc.6045","url":null,"abstract":"<div>\u0000 \u0000 <p>The four most used antimicrobial preservatives in biopharmaceutical parenteral formulations are phenol, meta-cresol, chlorobutanol, and benzyl alcohol. Preservatives are included in various combinations in biopharmaceuticals highlighting the importance of an analytical method to quantify the four preservatives simultaneously. A headspace GC–MS method was developed to quantify phenol, chlorobutanol, meta-cresol, and benzyl alcohol. The method was validated according to USP <1225>. System suitability <USP 621> was conducted daily for retention time (%RSD < 2.0%), peak area (%RSD < 5.0%), USP tailing factor (< 2.0 and %RSD < 10.0%), and peak resolution (> 2.0). Analytical ranges were 1.5–90 μg/mL for phenol and meta-cresol, 30–240 μg/mL for benzyl alcohol, and 30–300 μg/mL for chlorobutanol. Method accuracy ranged from 94% to 108% and precision from 4% to 15 %RSD for all the tested preservatives. The method was applied to three marketed teriparatide drug products selected as a model. Preservative concentrations of the biopharmaceutical marketed products were determined and were found to be comparable with the labeled concentrations, except for an expired product with 2.5% of the label claim. The developed headspace GC–MS method can be used to evaluate the drug quality of the parenteral formulations and to support the assessment of biopharmaceutical peptide drug products.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","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 Sennoside A in Rat Plasma by Liquid Chromatography/Electrospray Ionization Tandem Mass Spectrometry and Its Application to a Rat Pharmacokinetic Study 液相色谱/电喷雾离子化串联质谱法测定大鼠血浆中的番泻苷 A 并将其应用于大鼠药代动力学研究

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-18 DOI: 10.1002/bmc.6049

Jingjing Sun, Yifan Gu, Chunyan Gu, Wen Qi, Feifei Chu, Jiawei Shen

{"title":"Determination of Sennoside A in Rat Plasma by Liquid Chromatography/Electrospray Ionization Tandem Mass Spectrometry and Its Application to a Rat Pharmacokinetic Study","authors":"Jingjing Sun, Yifan Gu, Chunyan Gu, Wen Qi, Feifei Chu, Jiawei Shen","doi":"10.1002/bmc.6049","DOIUrl":"10.1002/bmc.6049","url":null,"abstract":"<div>\u0000 \u0000 <p>To characterize pharmacokinetic profile of sennoside A in rats after intravenous and oral administration, a simple and sensitive liquid chromatography tandem mass spectrometry method was established and validated for quantitative determination of sennoside A in rat plasma. After prepared by protein precipitation with acetonitrile, sennoside A and internal standard were separated on a Waters ACQUITY HSS T3 (2.1 × 100 mm, 1.8 μm) column using acetonitrile and 5-mM ammonium acetate in water as mobile phase by gradient elution. The method showed excellent linearity over the range of 0.5–1000 ng/mL with acceptable intra- and inter-day precision, accuracy, matrix effect, and recovery. The stability assay indicated that sennoside A was stable in plasma during the sample collection, preparation, and analysis. Next, the method was applied to pharmacokinetic study of sennoside A in rats. After intravenous and intragastric administrated to rats, the concentrations of sennoside A in plasma at different time points were quantitated and the pharmacokinetic parameters were calculated by software of DAS 2.0. Pharmacokinetic parameters suggested that after oral administration, sennoside A was reached to the peak at 2.9–3.6 h with a C<sub>max</sub> value of 13.2–31.7 ng/mL. Sennoside A was eliminated slowly from the plasma with T<sub>1/2</sub> value between 15.4 and 18.3 h. The oral absolute bioavailability was among 0.9%–1.3%, which indicated low blood exposure level.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142667235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Enantioselective Membranes for Pharmaceutical Applications: A Comprehensive Review 用于制药的对映体选择性膜：全面回顾。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-18 DOI: 10.1002/bmc.6043

Monti Gogoi, Rajiv Goswami, Akhil Ranjan Borah, Lachit Phukan, Swapnali Hazarika

{"title":"Enantioselective Membranes for Pharmaceutical Applications: A Comprehensive Review","authors":"Monti Gogoi, Rajiv Goswami, Akhil Ranjan Borah, Lachit Phukan, Swapnali Hazarika","doi":"10.1002/bmc.6043","DOIUrl":"10.1002/bmc.6043","url":null,"abstract":"<div>\u0000 \u0000 <p>In the past decade, significant advances have been made in the field of chiral separation, which is crucial for biological and pharmaceutical applications. Enantioselective membranes have emerged as a promising platform for efficient chiral separation due to their unique properties such as large surface area, tunable pore size, and high selectivity. These membranes are particularly effective in separating enantiomers because of their ability to facilitate selective interactions between the membrane material and chiral molecules. This article provides a comprehensive review of the recent progress in enantioselective membranes for chiral separation. Key topics discussed include various membrane fabrication methods, functionalization approaches, and the characterization of membrane properties, specifically in the context of applications like drug delivery, biomolecule separation, and pharmaceutical analysis. Furthermore, the review addresses the current challenges, potential solutions, and future prospects in this rapidly evolving field, highlighting the direction for upcoming research.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142667244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Novel analytical approach for baclofen quantification in rodent plasma. 啮齿动物血浆中巴氯芬定量的新型分析方法。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-13 DOI: 10.1002/bmc.6038

Bindu Dhiman, Mithlesh Yadav, Saurabh Satija, Anju Dhiman

引用次数: 0

Lingguizhugan decoction alleviates gestational diabetes mellitus by modulating the PI3K-AKT pathway and oxidative stress: Network pharmacology and experimental evidence. 通过调节 PI3K-AKT 通路和氧化应激缓解妊娠糖尿病：网络药理学和实验证据。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-12 DOI: 10.1002/bmc.6042

Chenyue Cao, Weiqin Chen, Bin Chen, Xiaoyu Wang, Yiling Lu, Xueqin Zou, Xinyi Kang, Liping Chen

{"title":"Lingguizhugan decoction alleviates gestational diabetes mellitus by modulating the PI3K-AKT pathway and oxidative stress: Network pharmacology and experimental evidence.","authors":"Chenyue Cao, Weiqin Chen, Bin Chen, Xiaoyu Wang, Yiling Lu, Xueqin Zou, Xinyi Kang, Liping Chen","doi":"10.1002/bmc.6042","DOIUrl":"https://doi.org/10.1002/bmc.6042","url":null,"abstract":"<p><p>The Lingguizhugan decoction (LGZGD) is a promising traditional Chinese medicine for the treatment of gestational diabetes mellitus (GDM). However, its bioactive compounds and therapeutic mechanisms remain unknown. The main chemical composition of LGZGD was analyzed by high-performance liquid chromatography-mass spectrometry (HPLC-MS). Furthermore, the underlying mechanisms of LGZGD against GDM were elucidated through network pharmacology and molecular docking. The therapeutic efficacy and targets of LGZGD were further confirmed via an in vitro GDM model (high glucose [HG]-treated HTR-8/SVneo cells). Four compounds of LGZGD, namely, cinnamaldehyde, glycyrrhizic acid, 2-atractylenolide, and pachymic acid, were detected. A total of 26 targets for LGZGD treating GDM were obtained, which were mainly involved in oxidative stress and the PI3K-AKT signaling pathway. The protein-protein interaction (PPI) network unveiled that AKT1, TLR4, TP53, and NOS3 were hub therapeutic targets. Molecular docking showed that these targets had strong affinity with key compounds. In vitro experiments confirmed that LGZGD treatment promoted HG-induced cell viability, migration, and invasion ability while inhibited the apoptosis rate and oxidative stress. Mechanically, western blot revealed that LGZGD may protect HG-treated cells by activating the PI3K-AKT pathway and suppressing TLR4 expression. Our study preliminarily explored the mechanism of LGZGD in GDM treatment, providing a scientific basis for the clinical application of LGZGD.</p>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":" ","pages":"e6042"},"PeriodicalIF":1.8,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Enantioseparation and enantiorecognition 对映体分离和对映体识别。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-10 DOI: 10.1002/bmc.6041

Ravi Bhushan

引用次数: 0

A novel, sensitive, and fast ultra-high-performance liquid chromatography tandem mass spectrometry method for TNG908 determination in dog plasma and pharmacokinetic study 一种新颖、灵敏、快速的超高效液相色谱串联质谱法测定狗血浆中的TNG908并进行药代动力学研究。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-07 DOI: 10.1002/bmc.6039

Weiwei Zhu, Huiying Zhang, Fan Li

{"title":"A novel, sensitive, and fast ultra-high-performance liquid chromatography tandem mass spectrometry method for TNG908 determination in dog plasma and pharmacokinetic study","authors":"Weiwei Zhu, Huiying Zhang, Fan Li","doi":"10.1002/bmc.6039","DOIUrl":"10.1002/bmc.6039","url":null,"abstract":"<p>TNG908 is a potent and selective protein arginase methyltransferase 5 (PRMT5) inhibitor that is currently going through phase I/II clinical development for the treatment of non-small cell lung cancer. To facilitate pharmacokinetic and toxicokinetic studies of TNG908, here, we reported an ultra-high-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the detection of TNG908 in dogs. The dog plasma samples were precipitated by acetonitrile and analyzed using a Waters ACQUITY BEH C<sub>18</sub> column combined with a Thermo triple quadrupole mass spectrometer. The mobile phase consisted of 0.1% formic acid solution and acetonitrile, at a flow rate of 0.3 mL/min. TNG908 and internal standard were monitored by selective reaction monitoring (SRM) with <i>m/z</i> 410.2 > 150.1 and <i>m/z</i> 394.2 > 278.1, respectively. The method demonstrated excellent linearity over the concentration range of 1–1000 ng/mL, with a correlation coefficient greater than 0.995. Acetonitrile-mediated protein precipitation showed high extraction efficiency and a recovery above 80%. The validated assay was further applied to measure TNG908 in dog plasma after oral and intravenous administration and achieved success. The obtained pharmacokinetic parameters indicated low clearance of TNG908 (3.7 ± 0.8 mL/min/kg) and moderate oral bioavailability (>36.4%).</p>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142602795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A headspace GC–MS method to quantify nitrosamine impurities and precursors in drug products: Method validation and product testing 一种顶空 GC-MS 方法，用于量化药物产品中的亚硝胺杂质和前体：方法验证和产品测试。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-07 DOI: 10.1002/bmc.6040

Susan Daniela Selaya, Nicolas Abrigo, Dustin G. Brown, Saaniya Desai, Christopher Beekman, Patrick Faustino, Diaa Shakleya

引用次数: 0

Method development and validation of an analytical quality by design ultrafast liquid chromatographic method for the determination of bedaquiline from pharmaceutical bulk and nanoemulsions 用于测定散装和纳米乳剂中的贝达喹啉的超快速液相色谱分析方法的开发与验证。

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2024-11-06 DOI: 10.1002/bmc.6037

Taiwo Oreoluwa Ajayi, Madan Sai Poka, Bwalya Angel Witika

{"title":"Method development and validation of an analytical quality by design ultrafast liquid chromatographic method for the determination of bedaquiline from pharmaceutical bulk and nanoemulsions","authors":"Taiwo Oreoluwa Ajayi, Madan Sai Poka, Bwalya Angel Witika","doi":"10.1002/bmc.6037","DOIUrl":"10.1002/bmc.6037","url":null,"abstract":"<p>Bedaquiline (BDQ) is a drug used to treat multidrug-resistant tuberculosis (MDR-TB). It exhibits exposure-dependent efficacy in eliminating <i>Mycobacterium tuberculosis</i> (Mtb). An easy, efficient and precise reverse-phase ultrafast liquid chromatography (RP-UFLC) method was developed to validate the free base of the antitubercular medication BDQ. BDQ was separated using a 10:90 v/v mobile phase of ammonium acetate buffer solution (pH = 5.4) and high-performance liquid chromatography–grade methanol, with a flow rate of 1.5 mL/min and a UV detection wavelength of 226 nm. By using the Box–Behnken design (BBD) and response surface methodology (RSM), the method was optimised by varying critical analytical attributes (CAA) and critical performance attributes (CPAs) namely ammonium acetate fraction (%), flow rate (ml/min), buffer system molarity (M) and pH. BDQ was eluted at 7.5 min utilising isocratic elution. The method was linear in the concentration range of 0.5–300 μg/mL with limit of detection values of 0.039 μg/mL and limit of quantification of 0.12 μg/mL. The results indicate that this validated method can be used as an alternative method for assay of BDQ.</p>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"38 12","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/bmc.6037","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0