Biomedical Chromatography最新文献

{"title":"A Validated, Stability-Indicating HPLC Method for the Simultaneous Determination of Five Related Substances in Liraglutide Drug Substance","authors":"Lixiang Zhang,&nbsp;Xinyu Li,&nbsp;Jiansong Zhang,&nbsp;Xiao Wang,&nbsp;Yuqing Fu","doi":"10.1002/bmc.70118","DOIUrl":"https://doi.org/10.1002/bmc.70118","url":null,"abstract":"<div>\u0000 \u0000 <p>Liraglutide, an analog of glucagon-like peptide-1, is a treatment for the management of type 2 diabetes mellitus and obesity. In this study, we developed and validated a straightforward, sensitive, and reproducible gradient reverse-phase high-performance liquid chromatographic method for the separation and quantification of related substances in liraglutide drug substance. A C8 column was employed as the chromatographic column, with a mobile phase comprising phosphate buffer solution and acetonitrile. Under optimized chromatographic conditions, five specific impurities within liraglutide could be efficiently separated simultaneously. The resolution between main peak and each impurity was greater than 1.0, and the tailing factor of the main peak was less than 1.0. This method exhibited high sensitivity and enabled quantitative determination of both liraglutide and each impurity, thereby effectively ensuring the quality control of liraglutide products. The developed method is validated in accordance with the guidelines set by the International Conference on Harmonization regarding specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144171534","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}

{"title":"Pharmacodynamic Material Basis and Pharmacological Mechanism of Huangqi Guizhi Wuwu Granules in Diabetic Peripheral Neuropathy","authors":"Yang Liu,&nbsp;Lele Li,&nbsp;Yan Yang,&nbsp;Xing Wang,&nbsp;Shengyu Ge,&nbsp;Lili Jin,&nbsp;Bo Feng,&nbsp;Jiao Guan,&nbsp;Heyun Zhu","doi":"10.1002/bmc.70127","DOIUrl":"https://doi.org/10.1002/bmc.70127","url":null,"abstract":"<div>\u0000 \u0000 <p>Huangqi Guizhi Wuwu Decoction (HGWD) is a traditional Chinese medicine (TCM) formula used to treat diabetic peripheral neuropathy (DPN) in China. Considering that the decoction was not easy to carry and use, we have prepared HGWD into Huangqi Guizhi Wuwu Granules (HGWG). However, the active components of HGWG that can be absorbed into plasma and its mechanism of action for DPN treatment remain unclear. In the present study, UHPLC-Q-TOF-MS and network pharmacology methods were applied to explore the potential pharmacodynamic material basis and pharmacological mechanism of HGWG for the treatment of DPN. A total of 31 absorbed components were detected in rat plasma, including 20 prototype compounds and 11 metabolites. Flavonoid-related metabolites and gingerol-related metabolites were major metabolites. The network pharmacological analysis showed that 31 absorbed constituents regulated 122 pathways through 177 targets; among them, baicalein, paeoniflorin C, and 6-gingerol were the main pharmacodynamic components of HGWG for DPN. It can be concluded that monoterpenoid glycosides, flavonoids, organic acids, gingerols, flavonoid-related metabolites, and gingerol-related metabolites were the main pharmacodynamic material basis of HGWG for DPN, and the mechanism of HGWG for DPN may be related to reducing oxidative stress and inhibiting neuroinflammation by stimulating the phosphorylation of p38 MAPK.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144171535","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}

{"title":"Simultaneous Determination of Glibenclamide, Metoprolol Tartrate, and Phenol Red Using HPLC-PDA: Application in Rat Intestinal Permeability Studies and Its Greenness Assessment Using NEMI, Analytical Eco-Scale, GAPI, MoGAPI, AGREE, AGREEprep, RAPI, BAGI, and CACI","authors":"Murat Soyseven,&nbsp;Mustafa Sinan Kaynak,&nbsp;Berna Kaval,&nbsp;Mustafa Çelebier,&nbsp;Emrah Aygeyik,&nbsp;Fargana Musayeva,&nbsp;Burcu Sezgin,&nbsp;Göksel Arli","doi":"10.1002/bmc.70128","DOIUrl":"https://doi.org/10.1002/bmc.70128","url":null,"abstract":"","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144148613","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}

{"title":"Stability-Indicating RP-HPLC Method Development and Validation for Quantification of Butylated Hydroxyanisole Content in Loperamide Oral Solid Dosage Form","authors":"Prasanna Kumar Lankalapalli,&nbsp;Srinivasulu Kasa,&nbsp;Pranitha Sambu,&nbsp;Rama Krishna Myneni,&nbsp;Teja Kamireddy,&nbsp;Vijaykumar chollety,&nbsp;Hareesh Divadari","doi":"10.1002/bmc.70103","DOIUrl":"https://doi.org/10.1002/bmc.70103","url":null,"abstract":"<div>\u0000 \u0000 <p>The present study discusses the development of a simple, rapid, and specific high-performance liquid chromatography (HPLC) method for the estimation of butylated hydroxyanisole (BHA) in loperamide HCl capsule dosage formulations. The developed HPLC method was validated in accordance with current ICH guidelines. Chromatographic separation was achieved using a phosphate buffer (pH 6.8) as mobile phase A and a mixture of acetonitrile and buffer in a ratio of 80:20 (v/v) as mobile phase B. The flow rate was 0.8 mL/min, and column temperature was maintained at 35°C. Detection of the component was performed at 290 nm for BHA. The optimized HPLC method was validated as per current ICH guidelines and demonstrated high specificity with a linearity range of 13–83 μg/mL for BHA, with a correlation coefficient greater than 0.999. The method showed accuracy exceeding 97%. Stress studies revealed that BHA is sensitive to peroxide stress conditions. The results highlight the successful applicability of the current method for estimating BHA in marketed formulations, which can be further utilized to evaluate other formulation systems. The developed method was validated according to international ICH guidelines concerning specificity, linearity, precision, and accuracy. The method was developed and validated in a quality control lab for stability analysis.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144140666","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}

{"title":"Preliminary Metabolomics Data Reveals Lipid Metabolism and Oxidative Stress Metabolites as Potential Biomarkers for Patent Ductus Arteriosus","authors":"Mustafa Çelebier,&nbsp;Aybuke Yazici,&nbsp;Duygu Eneş,&nbsp;Abdullah Kurt,&nbsp;Bilge Başak Fidan,&nbsp;Ibrahim Ilker Cetin,&nbsp;Dilek Sahin,&nbsp;Evrim Alyamac Dizdar,&nbsp;Fatma Nur Sari","doi":"10.1002/bmc.70125","DOIUrl":"https://doi.org/10.1002/bmc.70125","url":null,"abstract":"<div>\u0000 \u0000 <p>Patent ductus arteriosus (PDA) is a common congenital heart defect in preterm infants and is associated with significant morbidity. Early diagnosis is crucial but challenging due to nonspecific clinical symptoms. This study aims to identify potential metabolomic biomarkers for early detection of PDA using human cord blood. A prospective cross-sectional study was conducted involving 45 preterm infants between 23^0/6 and 31^6/7 weeks of gestation. The diagnosis of hemodynamically significant PDA (hsPDA) was based on echocardiographic findings after 48 h, showing a left atrium-to-aortic root ratio &gt; 1.5 and/or a ductus diameter &gt; 1.5 mm. Untargeted metabolomics analysis was performed on cord blood plasma samples using quadrupole time-of-flight liquid chromatography-mass spectrometry (Q-TOF LC/MS). Data were processed for metabolites that differed between groups. Twenty infants with hsPDA formed the study group, 25 controls. Out of 4237 detected peaks, 40 showed statistically significant differences (fold change &gt; 1.5,<i>p</i> &lt; 0.05). Among these, 15 metabolites were potentially clinically relevant. Key findings included decreased levels of guanidino acetic acid, <i>S</i>-adenosylmethionine, and ceramides and increased levels of docosahexaenoic acid, arachidonic acid, and cholesterol-related molecules in the PDA group. The study reveals significant metabolic alterations in lipid metabolism and oxidative stress-related pathways in PDA infants. Further targeted metabolomics studies are warranted to validate and explore clinical applications.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144140667","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}

{"title":"Development and Validation of the LC–MS/MS Method and Its Application for Pharmacokinetic Studies for the Simultaneous Estimation of Motixafortide and Filgrastim in rat Plasma","authors":"Lurdhu Mary K,&nbsp;Naresh Podila,&nbsp;Afzal B. Shaik,&nbsp;Jithendra Chimakurthy","doi":"10.1002/bmc.70126","DOIUrl":"https://doi.org/10.1002/bmc.70126","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Motixafortide, a CXCR4 antagonist, and filgrastim, a granulocyte colony-stimulating factor, have shown significant potential in enhancing hematopoietic stem cell mobilization and improving cancer treatment outcomes when used in combination. However, critical challenges persist due to the absence of analytical methods and the necessity for reliable quantification of both drugs in biological matrices. This research aims to address these gaps by developing and validating a liquid chromatography–tandem mass spectrometry method for the simultaneous quantification of motixafortide and filgrastim in rat plasma.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Experiment</h3>\u0000 \u0000 <p>An isocratic mobile phase with acetonitrile and buffer was employed for separation, following protein precipitation with acetonitrile, using a C₁₈ Waters X-Terra RP-18 column (150x4.6 mm,3.5 μm). Liquid chromatography–tandem mass spectrometry with an internal standard employs multiple reaction monitoring in electrospray ionization (positive ion mode) to monitor the transitions. The method was validated according to USFDA guidelines, assessing parameters such as selectivity, matrix effect, linearity, precision, accuracy, lower limit of quantification, and stability.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>This method was successfully applied in pharmacokinetic studies, ensuring reliable and accurate quantification of co-administered motixafortide and filgrastim. These findings significantly contribute to optimizing therapeutic protocols and enhancing treatment outcomes for cancer patients.</p>\u0000 </section>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144140556","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}

{"title":"Study on the Efficacy and Mechanism of Metabolomics and Bioinformatics on the Treatment of Qi Stagnation and Blood Stasis Coronary Heart Disease by Danshen Injection","authors":"Lei Wu,&nbsp;Mei Feng,&nbsp;You Peng,&nbsp;Yuyang Xiang,&nbsp;Rihui Liu,&nbsp;Tao Liu","doi":"10.1002/bmc.70120","DOIUrl":"https://doi.org/10.1002/bmc.70120","url":null,"abstract":"<div>\u0000 \u0000 <p>This study, grounded in traditional Chinese medicine theory, established a QZXY-CHD model to investigate DSI's impact on vascular endothelial function, inflammatory factors, oxidative stress, and myocardial energy metabolism from a holistic perspective. The results demonstrated that DSI significantly reduced serum levels of ET-1, MPO, IL-1β, TNF-α, MDA, LDH, and CK-MB, while increasing NO and SOD levels, indicating DSI's ability to inhibit inflammation, mitigate oxidative stress, and protect endothelial and organ functions. Using bioinformatics, we identified differentially expressed genes and metabolic pathways in coronary heart disease and screened diagnostic biomarkers (JDP2, ZFP36, TRAF3IP3, MRPS30, CLEC4D). Non-targeted metabolomics revealed changes in endogenous metabolites, identifying 73 differential metabolites between the control (Con) and model (Mod) groups, and 75 between the Mod and DSI groups, with 21 key overlapping metabolites. Integrated bioinformatics and metabolomics analysis highlighted critical metabolites such as arachidonic acid, leukotriene B4, linoleic acid, sucrose, D-glucose, pyroglutamic acid, and palmitic acid, as well as seven key metabolic pathways including arachidonic acid metabolism, linoleic acid metabolism, and galactose metabolism. This combined analysis provides biological evidence for identifying biomarkers of CHD host susceptibility and elucidates the mechanisms by which DSI ameliorates QZXY-CHD, offering new insights for diagnosis and disease management.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144140606","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}

{"title":"Comparison and Characterization of Polysaccharides From Various Sources and Before and After Honey Processing of Astragali Radix Utilizing Saccharide Mapping","authors":"Aoli Shang,&nbsp;Yadong Li,&nbsp;Ying Zhao,&nbsp;Jun Chen","doi":"10.1002/bmc.70121","DOIUrl":"https://doi.org/10.1002/bmc.70121","url":null,"abstract":"<div>\u0000 \u0000 <p>This study aimed to investigate the differences in polysaccharides in Astragali Radix (AR) from different sources, as well as before and after honey processing, through the analysis of enzymatic hydrolysates. The hydrolysis product of astragalus polysaccharides (APS) by β-galactosidase was characterized using hydrophilic interaction ultra-high-performance liquid chromatography coupled with time-of-flight mass spectrometry (HILIC-UHPLC-QTOF/MS). The results indicated that all oligosaccharide fragments were composed of hexoses, with sugar groups linked by 1,6-glycosidic bonds. APS enzymatic hydrolysates fingerprints were established using hydrophilic interaction high-performance liquid chromatography with an evaporative light scattering detector (HILIC-HPLC-ELSD) and comprehensively evaluated based on their similarity. Semi-quantitative analysis of each enzymatic hydrolysate was performed, combined with partial least squares discriminant analysis (PLS-DA) and significance testing to further analyze the main differential sugar fragments of AR in different growth modes and before and after honey processing. Glucose and oligosaccharides with degree of polymerization (DP) of 5 and 6 were identified as indicators to distinguish different growth modes. Glucose can serve as an indicator to distinguish raw AR from honey-processed AR (HAR). This study identified quality evaluation indicators of APS based on saccharide mapping, providing a reference for the development of quality standards for AR.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144140668","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}

{"title":"An Integrated Strategy Based on Metabolomics and Pharmacodynamics to Study the Mechanism of Action of Curcumin on the Animal Model of Dysmenorrhea","authors":"Zhimin Chen,&nbsp;Jie Wu,&nbsp;Fuli Hu,&nbsp;Mingyue Ao,&nbsp;Ying Peng,&nbsp;Yu Huang,&nbsp;Kaipei Luo,&nbsp;Changjiang Hu","doi":"10.1002/bmc.70124","DOIUrl":"https://doi.org/10.1002/bmc.70124","url":null,"abstract":"<div>\u0000 \u0000 <p>Curcumin is a natural food additive with significant biological activity, which is getting more and more attention in treating dysmenorrhea. But the underlying mechanism of action remains unclear. The objective of this study is to evaluate the therapeutic effect of curcumin on dysmenorrhea rats and reveal the underlying mechanism by metabolomics and pharmacodynamics. The dysmenorrhea rats were constructed by chronic unpredictable stress plus isolation feeding and subcutaneous injection of estradiol benzoate and oxytocin. The results demonstrate that curcumin can inhibit the writhing response, regulate liver function indexes such as ALT and AST to normal levels, significantly reverse the levels of AVP and PEG2, promote the stability of hormone levels in the body, and repair damaged uterine tissue. Moreover, 75 differential metabolites were screened, among which curcumin significantly regulated 19 differential metabolites related to the treatment of dysmenorrhea, involving five metabolic pathways including phenylalanine, tryptophan, and tryptophan biosynthesis, phenylalanine metabolism, etc. Curcumin has a good therapeutic effect on dysmenorrhea, which may be related to its anti-inflammatory and hepatoprotective effects and regulation of a variety of metabolic pathways, which highlights the broad application prospect of curcumin in the treatment of dysmenorrhea.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144140669","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}

{"title":"Rapid and Systematic Characterization of Chemical Constituents in Astragali radix–Curcumae rhizoma Herb Pair Using an UPLC-QTOF-MS–Based Strategy","authors":"Qi-Rui He,&nbsp;Ya-Cong Chen,&nbsp;Ming-Xia Lu,&nbsp;Rui-Qian Sun,&nbsp;Sha-Sha Wang,&nbsp;Xue Qiu,&nbsp;Qian-Lu Ma,&nbsp;Chang-Yin Li,&nbsp;Xi-Ying Tan","doi":"10.1002/bmc.70097","DOIUrl":"https://doi.org/10.1002/bmc.70097","url":null,"abstract":"<div>\u0000 \u0000 <p><i>Astragali radix</i>–<i>Curcumae rhizoma</i> (AC), a traditional Chinese herb pair, has been extensively used in clinical practice for the treatment of various types of cancer. However, there is a paucity of literature that comprehensively elucidates the chemical constituents of AC. The complex composition of AC remains poorly understood, with many constituents yet to be fully distinguished. Therefore, a strategy was established for identifying and characterizing the chemical constituents of AC based on ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS). Furthermore, the exploratory quantitative analysis was conducted on its representative compounds using a calibration curve method. The results showed that a total of 140 compounds were identified, including 40 flavonoids, 50 sesquiterpenes, 15 amino acids, 13 saponins, 6 organic acids, 4 curcumins, 4 nucleosides, and 8 other compounds. Among the 24 compounds determined, calycosin-7-glucoside was found to have the highest content. In conclusion, this study has developed a reliable qualitative strategy and an exploratory quantitative method and systematically characterized the chemical constituents in AC, which lays a solid foundation for quality control of AC, as well as for the further screening of potential effective constituents.</p>\u0000 </div>","PeriodicalId":8861,"journal":{"name":"Biomedical Chromatography","volume":"39 7","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144135791","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}