Biomedical Chromatography最新文献

A Simple Eco-Friendly Stability-Indicating HPLC Method for Determination of NETILMICIN in Bulk and Ophthalmic Solution 一种简便、环保、稳定性指示的高效液相色谱法测定原料药和眼药水中奈替米星的含量

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-23 DOI: 10.1002/bmc.70152

Ahmed Sobhy Darwish, Mohamed Samir Ahmed Zaki, Ali GadKarim A. Salih, Mohamed Abd Ellatif, Ayyub Ali Patel, Ayaz Khurram Mallick, Marya Ahsan, Wageh Sobhy Darwish

{"title":"A Simple Eco-Friendly Stability-Indicating HPLC Method for Determination of NETILMICIN in Bulk and Ophthalmic Solution","authors":"Ahmed Sobhy Darwish, Mohamed Samir Ahmed Zaki, Ali GadKarim A. Salih, Mohamed Abd Ellatif, Ayyub Ali Patel, Ayaz Khurram Mallick, Marya Ahsan, Wageh Sobhy Darwish","doi":"10.1002/bmc.70152","DOIUrl":"https://doi.org/10.1002/bmc.70152","url":null,"abstract":"<div>\u0000 \u0000 <p>The aim of our study was the development and validation of an eco-friendly stability-indicating method for the determination of netilmicin in bulk and in ophthalmic solution. The mobile phase was composed of 40-mL ethanol and 960-mL buffer solution at a pH of 3.5, which was prepared by using 1-hexane sodium sulfonate and anhydrous sodium sulfate, at a flow rate of 1 mL/min. The detecting wavelength was 205 nm, the injection volume was 20 μL, the analysis runtime was < 7 min, and the focus was on netilmicin concentration levels of 125.0–1000.0 μg/mL. The method's environmental friendliness was demonstrated by the conclusional AES of 87, the AGREE of 0.65, the MoGAPI of 76 with six green pieces, the BAGI score of 77.5, and the whiteness of 99.2. The method that is being provided demonstrates exceptional attributes including cost-effectiveness, ICH validation items, and environmental friendliness.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 8","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144367224","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 for the Quantification of Genotoxic Impurity in Mirabegron Drug Substance by LCMS micabegron原料药中遗传毒性杂质的LCMS定量方法的建立与验证

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-23 DOI: 10.1002/bmc.70150

Haresh B. Patel, Rohit H. Dave, Sandip Vadariya, Hitin Hirpara

{"title":"Development and Validation for the Quantification of Genotoxic Impurity in Mirabegron Drug Substance by LCMS","authors":"Haresh B. Patel, Rohit H. Dave, Sandip Vadariya, Hitin Hirpara","doi":"10.1002/bmc.70150","DOIUrl":"https://doi.org/10.1002/bmc.70150","url":null,"abstract":"<div>\u0000 \u0000 <p>The mirabegron drug substance was shown to have potential genotoxic impurity (PGI); hence, it needs to develop the method for the determination of the 2-(2-Nitrophenyl) ethylamine hydrochloride (4-NPE RC-2) PGI at a 30-ppm limit considering the maximum daily dose of 50 mg/day and a 1.5 mg per day TTC limit as per ICH M7 guideline. A simple high-performance liquid chromatography (HPLC) method can be used due to the chromophore nature of the impurity, but due to sample matrix interference on the HPLC method, a selective and specific method was developed using liquid chromatography-mass spectrometry (LC–MS/MS) method. Using an Inertsil ODS 3-V column, gradient elution mode, 0.8 mL per min flow rate, 0.2% formic acid aqueous solution as mobile phase A, and acetonitrile solvent as mobile phase B was used for better chromatographic separation. Triple quadrupole mass detection with electrospray ionization (ESI) in multiple reaction monitoring (MRM) mode was used for determination and quantification. For this PGI, the procedure was thoroughly verified with good linearity across the mirabegron test concentration range of 9–45 ppm. Linearity was observed with an exceeding 0.990 correlation coefficient and found accuracy in terms of recovery between 100.0% and 103.0% with below 5.0% relative standard deviation.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 8","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144367225","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 an RP-HPLC Method for Organic Impurity Profiling in Baclofen Utilizing Robustness Through a Quality-by-Design (QbD) Approach: A Comprehensive Forced Degradation Assessment 基于设计质量（QbD）方法鲁棒性的巴氯芬有机杂质分析RP-HPLC方法的建立与验证：一种全面的强制降解评估

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-23 DOI: 10.1002/bmc.70129

Santhosh Kumar Ettaboina, Satyasree Nannapaneni, Naresh Kumar Katari, Vijay Kumar Chollety

{"title":"Development and Validation of an RP-HPLC Method for Organic Impurity Profiling in Baclofen Utilizing Robustness Through a Quality-by-Design (QbD) Approach: A Comprehensive Forced Degradation Assessment","authors":"Santhosh Kumar Ettaboina, Satyasree Nannapaneni, Naresh Kumar Katari, Vijay Kumar Chollety","doi":"10.1002/bmc.70129","DOIUrl":"https://doi.org/10.1002/bmc.70129","url":null,"abstract":"<div>\u0000 \u0000 <p>Strong understandings of science and risk evaluation methodologies are needed to design an analytical method for pharmaceutical quality assessment. This article provides an HPLC method for separating and quantifying baclofen and related impurities. The technique used a Waters Symmetry C<sub>18</sub> column, 250 × 4.6 mm, 5 μm in gradient mode. Mobile Phase A was prepared by dissolving 0.0128 M of 1-octane sulfonic acid sodium salt in water, followed by the addition of 1 mL of orthophosphoric acid and 2 mL of tetrabutylammonium hydroxide to make up to a solution of 1 L. Mobile Phase B was a homogenous mixture of methanol and water in a 900:100 (v/v) ratio. A 0.7-mL/min flow rate was maintained for 60 min. The sample cooler and column temperatures were kept at 25°C and 32°C with a 10-μL injection volume. The detecting wavelength was 225 nm. The drug product and material were subjected to acidity, base, oxidation, heat, and photolysis according to International Conference on Harmonization (Q2) criteria. A linear response (<i>R</i><sup>2</sup> > 0.999), accuracy (recoveries 97.1%–102.5%), precision (RS ≤ 5.0%), sensitivity, and specificity were demonstrated by the proposed method. This method ensures reliable analytical performance by cleanly separating compounds. Final method conditions were assessed using a full-factorial design. Graphical optimization from the design space identified robust technique conditions.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 8","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144367226","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 an HPLC-RI Method for the Simultaneous Determination of DPPC, Palmitic Acid, and Cholesterol in Bovine Pulmonary Surfactant HPLC-RI同时测定牛肺表面活性剂中DPPC、棕榈酸和胆固醇的方法的建立和验证

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-19 DOI: 10.1002/bmc.70151

Mahsa Aghaei, Mahjoobeh Ehsani, Malihe Keramati

{"title":"Development and Validation of an HPLC-RI Method for the Simultaneous Determination of DPPC, Palmitic Acid, and Cholesterol in Bovine Pulmonary Surfactant","authors":"Mahsa Aghaei, Mahjoobeh Ehsani, Malihe Keramati","doi":"10.1002/bmc.70151","DOIUrl":"https://doi.org/10.1002/bmc.70151","url":null,"abstract":"<div>\u0000 \u0000 <p>This study aimed to develop and validate an HPLC-RI method for the simultaneous determination of dipalmitoylphosphatidylcholine (DPPC), palmitic acid, and cholesterol in bovine pulmonary surfactant, a critical treatment for infants suffering from Respiratory Distress Syndrome (RDS). The Iranian surfactant, Beraksurf, was used as the sample. A simple extraction procedure involving methanol dissolution and protein precipitation was employed, followed by HPLC analysis. The method underwent comprehensive validation for various parameters, including system suitability, repeatability (intra-assay precision), intermediate precision, linearity, accuracy, limit of detection (LOD), limit of quantification (LOQ), and robustness. The results demonstrated excellent system suitability. Repeatability and intermediate precision were confirmed with low %RSD values, while linearity was established with correlation coefficients (<i>R</i><sup>2</sup>) exceeding 0.99 for all analytes. The method exhibited high accuracy, with recoveries ranging from 97% to 100%, and low LOD and LOQ values, indicating its sensitivity. Robustness testing revealed that minor variations in method parameters did not significantly impact results. This validated RP-HPLC-RID method provides a reliable and efficient approach for the analysis of key surfactant components, contributing to improved quality control in surfactant preparations and enhancing therapeutic strategies for managing RDS in infants.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 8","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144323732","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

Investigation of the Protective Effect of Red-Light-Intervened Dendrobium officinale on Rats With Gastric Injury Based on Serum Metabolomics 基于血清代谢组学研究红光干预铁皮石斛对胃损伤大鼠的保护作用

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-18 DOI: 10.1002/bmc.70135

Huimin Luo, Xuejing Dong, Long Chen, Fengfeng Xie, Liba Xu, Miao Zhang, Hua Zhu, Jianbei Teng, Zhonghua Dai, Xiuqi Yu

{"title":"Investigation of the Protective Effect of Red-Light-Intervened Dendrobium officinale on Rats With Gastric Injury Based on Serum Metabolomics","authors":"Huimin Luo, Xuejing Dong, Long Chen, Fengfeng Xie, Liba Xu, Miao Zhang, Hua Zhu, Jianbei Teng, Zhonghua Dai, Xiuqi Yu","doi":"10.1002/bmc.70135","DOIUrl":"https://doi.org/10.1002/bmc.70135","url":null,"abstract":"<div>\u0000 \u0000 <p>This study aimed to compare both the protective effects and metabolic mechanisms of red-light-cultured <i>Dendrobium officinale</i> (RL-DO) and natural-light-cultured <i>D. officinale</i> (NL-DO) on gastric injury in rats. Rats were divided into control, model, omeprazole, RL-DO, and NL-DO groups. After 24-day treatment, gastric mucosal pathology, serum biomarkers (Gas, MTL, and SS), oxidative stress markers (SOD, MDA, and NO), apoptosis-related proteins (Bax/Bcl-2 and Caspase-3), and serum metabolomics were analyzed via HE staining, ELISA, Western blot, TUNEL, and UHPLC-Q-Exactive Plus-MS. Both RL-DO and NL-DO significantly improved gastric mucosal damage, upregulated SOD/NO, downregulated MDA, reduced apoptosis, and modulated Bax/Bcl-2/Caspase-3 (<i>p</i> < 0.05/0.01). RL-DO exhibited superior efficacy in enhancing body weight, water intake, fecal moisture, and NO levels. Metabolomics revealed RL-DO reversed 46 metabolites (vs. NL-DO's 37) and targeted key pathways including glycerophospholipid metabolism, apoptosis regulation, and cAMP signaling. RL-DO uniquely regulated arginine/proline metabolism and fatty acid biosynthesis. Both RL-DO and NL-DO protect against gastric injury, with RL-DO showing enhanced efficacy, likely due to broader metabolic pathway modulation.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 8","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309033","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

Thermodynamic and Extra-Thermodynamic Investigations of Bioactive Compounds With Endothelin A Receptor by Nonlinear Chromatography 非线性色谱法研究内皮素A受体生物活性化合物的热力学和热力学外性质

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-18 DOI: 10.1002/bmc.70149

Chan Li, Yanbing Zhu, Yu Fang

{"title":"Thermodynamic and Extra-Thermodynamic Investigations of Bioactive Compounds With Endothelin A Receptor by Nonlinear Chromatography","authors":"Chan Li, Yanbing Zhu, Yu Fang","doi":"10.1002/bmc.70149","DOIUrl":"https://doi.org/10.1002/bmc.70149","url":null,"abstract":"<div>\u0000 \u0000 <p>Understanding the thermodynamic and extra-thermodynamic interactions of a ligand to its target can provide important insights into ligand affinity and efficiency. Using endothelin receptor A (ET<sub>A</sub>R) as an example, ET<sub>A</sub>R was immobilized on ibrutinib-modified silica gels to prepare affinity stationary phase. After specificity and stability characterization, the affinity column was utilized to investigate the interactions between four ligands with ET<sub>A</sub>R. The four ligands were ambrisentan, paeoniflorin (PAE), ferulic acid (FA), and salvianolic acid B (SAB). Nonlinear chromatography was applied to determine the affinities of the ligands with ET<sub>A</sub>R at temperature range of 283.15~318.15 K. Entropy change (Δ<i>H</i>), enthalpy change (Δ<i>S</i>), and Gibbs free energy change (Δ<i>G</i>) were determined. The Δ<i>H</i> and Δ<i>S</i> remain constant for ambrisentan and PAE. While enthalpy–entropy compensation happened for FA and SAB, indicating conformational changes occurred during the binding of them with ET<sub>A</sub>R. PAE had similar thermodynamic behaviors to ambrisentan (an approved drug targeting ET<sub>A</sub>R for the treatment of pulmonary arterial hypertension), implying that the ligand has greater possibilities to be a lead than FA and SAB. This result was also confirmed by a survey of DrugBank. Together, the method may become an alternative for predicting the druglike property of a newly discovered bioactive compound.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 8","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144315244","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

Study on Quality Evaluation of Processed Cimicifuga Rhizoma Based on UPLC Fingerprint and Chemometrics 基于UPLC指纹图谱和化学计量学的枸杞子炮制品质量评价研究

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-18 DOI: 10.1002/bmc.70141

Lihua Tan, Na Li, Guoqin Zhang, Zhenyu Zhou, Yanan Liu, Meng Wang, Xiaoliang Ren

{"title":"Study on Quality Evaluation of Processed Cimicifuga Rhizoma Based on UPLC Fingerprint and Chemometrics","authors":"Lihua Tan, Na Li, Guoqin Zhang, Zhenyu Zhou, Yanan Liu, Meng Wang, Xiaoliang Ren","doi":"10.1002/bmc.70141","DOIUrl":"https://doi.org/10.1002/bmc.70141","url":null,"abstract":"<div>\u0000 \u0000 <p>Cimicifuga Rhizoma, a traditional Chinese medicinal herb for treating toothache, aphtha, and measles, is also used as a dietary supplement for menopausal and osteoporosis management. Its therapeutic variability hinges on diverse processing methods, yet systematic quality assessment remains elusive. Here, nine processed Cimicifuga products were prepared following pharmacopoeia and classical protocols. Ultra-high performance liquid chromatography (UPLC) fingerprints integrated with multivariate chemometrics-hierarchical clustered heatmap (HCH), principal component analysis (PCA), and orthogonal partial least squares-discriminant analysis (OPLS-DA) revealed three distinct clusters. Variable importance projection (VIP > 1) identified caffeic acid, ferulic acid, and isoferulic acid as key markers. Quantitative analysis demonstrated that heating temperature and duration critically influenced these phenolic acids: steaming significantly increased all three, with caffeic acid, ferulic acid, and isoferulic acid contents rising by 1.71-, 1.27-, and 1.02-fold, respectively, whereas carbonization selectively elevated isoferulic acid by 3.03-fold. This chemometric-driven approach establishes a simplified yet robust framework for quality evaluation, linking processing parameters (e.g., thermal conditions) to chemical profiles. By bridging traditional processing knowledge with modern analytical rigor, the study provided actionable insights for standardizing Cimicifuga Rhizoma derivatives in clinical and industrial contexts.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 8","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309035","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

Pharmacodynamic Substance Basis and Anti-Cervicitis Efficacy Study of Jing Dai Ning Jiao Nang Based on UHPLC-Q-TOF-MS/MS Technology 基于UHPLC-Q-TOF-MS/MS技术的静代宁娇女药效学、物质基础及抗宫颈炎疗效研究

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-17 DOI: 10.1002/bmc.70146

Ling Yuan, Xiao Liang, Huan Wu, Wenmin Wang, Liye Xu, Yulin Feng, Wugang Zhang

{"title":"Pharmacodynamic Substance Basis and Anti-Cervicitis Efficacy Study of Jing Dai Ning Jiao Nang Based on UHPLC-Q-TOF-MS/MS Technology","authors":"Ling Yuan, Xiao Liang, Huan Wu, Wenmin Wang, Liye Xu, Yulin Feng, Wugang Zhang","doi":"10.1002/bmc.70146","DOIUrl":"https://doi.org/10.1002/bmc.70146","url":null,"abstract":"<div>\u0000 \u0000 <p>Jing Dai Ning Jiao Nang (JDNJN), a traditional Miao medicine from Guizhou Province, demonstrates clinical efficacy in treating gynecological disorders like dysmenorrhea but lacks mechanistic clarification. This study investigated JDNJN's anti-cervicitis effects and pharmacological basis using a 25% phenol mucilage-induced rat cervicitis model. The efficacy of JDNJN was evaluated through pathological examination, peripheral blood tests, HE staining, and ELISA assays. UHPLC-Q-TOF-MS/MS was used to analyze the chemical components of JDNJN, as well as prototype compounds and metabolites in the plasma, urine, and feces of rats after administration. The results showed that JDNJN ameliorated cervicitis-induced alterations in body weight, vulvar inflammation, organ index, white blood cell count, and cervical tissue structure in rats, and exerted therapeutic effects by regulating inflammatory cytokines. Additionally, 98 compounds were identified in JDNJN, primarily flavonoids, with 17 prototype compounds and 60 metabolites detected post-administration. Key metabolic pathways included deoxygenation, hydroxylation, methylation, hydroxylation combined with methylation, and sulfation. These findings establish the anti-inflammatory effect of JDNJN on cervicitis and clarify its pharmacodynamic material basis. This study provides foundational evidence for further exploration of JDNJN's active components and molecular mechanisms.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144300479","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

Simultaneous Determination of Atezolizumab and Bevacizumab by LC–MS/MS in Rat Plasma and Its Application to a Pharmacokinetic Study LC-MS /MS同时测定大鼠血浆中阿特唑单抗和贝伐单抗的含量及其在药代动力学研究中的应用

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-17 DOI: 10.1002/bmc.70139

Sudha Divya Madhuri Kallam, Mithun Rudrapal, Anoop Bodapati

{"title":"Simultaneous Determination of Atezolizumab and Bevacizumab by LC–MS/MS in Rat Plasma and Its Application to a Pharmacokinetic Study","authors":"Sudha Divya Madhuri Kallam, Mithun Rudrapal, Anoop Bodapati","doi":"10.1002/bmc.70139","DOIUrl":"https://doi.org/10.1002/bmc.70139","url":null,"abstract":"<div>\u0000 \u0000 <p>A robust, rapid, and highly sensitive LC–MS/MS method was developed and validated for the simultaneous quantification of atezolizumab and bevacizumab in rat plasma, with potential applications in pharmacokinetic studies. The mobile phase comprised water with 0.1% formic acid (mobile phase A) and acetonitrile with 0.1% formic acid (mobile phase B) in an isocratic ratio of 30:70, providing optimal separation on an Agilent Eclipse XDB column (250 mm × 4.6 mm, 5 μm). The selected peptides for atezolizumab (IYPTNGYTR) and bevacizumab (LTVLHQDWLNGK) yielded parent ions at <i>m/z</i> 579.78 and 686.38, and daughter ions at 746.36 and 859.44, respectively. The internal standard, abciximab, used the peptide VQWLQAGK with parent and daughter ions at <i>m/z</i> 471.26 and 590.32, respectively. Atezolizumab and bevacizumab were validated over linear ranges of 3.00–120 ng/mL and 1.25–50.00 ng/mL, showing excellent correlation coefficients (<i>r</i><sup><i>2</i></sup> = 0.999). Method accuracy for atezolizumab ranged from 96.76% to 99.55%, with precision (%CV) between 0.09% and 2.45% across quality controls, while bevacizumab demonstrated accuracy from 97.05% to 99.82% with precision (%CV) ranging from 0.09% to 8.82%. Matrix effects at low and high QC levels confirmed consistency, with accuracy and precision for atezolizumab and bevacizumab exceeding ICH guidelines. This optimized method offers a valuable tool for pharmacokinetic profiling of atezolizumab and bevacizumab in rat plasma, providing insights for therapeutic monitoring and drug development.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144300480","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

Correction to “[Differences Between Novel Hybrid Mode Flaps and Traditional Perforator Flaps at the Level of Metabolites Using LC-MS]” 对“[使用LC-MS分析新型杂交模式皮瓣与传统穿孔皮瓣在代谢物水平上的差异]”的更正

IF 1.8 4区医学

Biomedical Chromatography Pub Date : 2025-06-17 DOI: 10.1002/bmc.70148

引用次数: 0