Journal of pharmaceutical and biomedical analysis最新文献

{"title":"An efficient approach to probe bioactive components of herbal patches by 2D-carbon microfiber fractionation and multi-chamber membrane separation electrophoresis: Spatholobus suberectus Dunn as a case","authors":"Lei Yang ,&nbsp;Haiyan Cui ,&nbsp;Meiyu Cui ,&nbsp;Yu Qiu ,&nbsp;Miao Shao ,&nbsp;Yuwei Zhu ,&nbsp;Yonglong Liu ,&nbsp;Donatella Nardiello ,&nbsp;Maurizio Quinto ,&nbsp;Hai-Bo Shang ,&nbsp;Huwei Liu ,&nbsp;Donghao Li","doi":"10.1016/j.jpba.2025.116791","DOIUrl":"10.1016/j.jpba.2025.116791","url":null,"abstract":"<div><div>Herbal patches are widely used in clinics for their good curative effects. However, due to the complexity of plant matrices and the extremely low content of transdermal components, the individuation of their effective bioactive compounds represents a challenge: there is then a great need for an efficient method to reveal the bioactive ingredients of herbal patches. In this work, a wide-screening approach is proposed to an individuation of transdermal bioactive components in herbal patches obtained by <em>Spatholobus suberectus</em> Dunn (<em>S. suberectus</em>). Using a two-dimensional microscale carbon fiber/active carbon fiber system combined with a quadrupole time-of-flight high-resolution mass spectrometry (2DµCFs-QTOF-HRMS), a rapid and comprehensive analysis, lasting only 5 min, allowed the identification of 45 distinct polar components within <em>S. suberectus</em> extracts. Among these, 30 components exhibited a transdermal penetration estimated at values higher than 10 %. The key target, predicted by bioinformatics, was prostaglandin-endoperoxide synthase 2 (PTGS2). From the transdermal components of <em>S. suberectus,</em> four potential inhibitors of PTGS2 (protocatechuic acid, isoliquiritigenin, medicarpin, and catechin) were screened by multi-chamber membrane separation electrophoresis (MCMSE). The presence of binding pockets and action sites for medicarpin, isoliquiritigenin, and catechin determines higher binding energy towards PTGS2, with lower IC₅₀ values (12.27, 9.08, and 41.68 μM, respectively). The high-throughput and high-sensitivity analysis by 2DµCFs-QTOF-HRMS, combined with a high-accuracy screening of MCMSE, provides strong technical support for the discovery of trace transdermal bioactive components of herbal patches. The integration of the two technologies could accelerate the study of action mechanisms, quality control, and product improvement of herbal patches.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116791"},"PeriodicalIF":3.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143592043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Network analysis and experimental validation analysis reveal the mechanism by which psoralen improves glucocorticoid-induced growth retardation","authors":"Wenxiang Zeng ,&nbsp;Ying Zhao ,&nbsp;Qingyu Tu ,&nbsp;Xin Chen ,&nbsp;Shiqiao He ,&nbsp;Wenla Wang ,&nbsp;Zhenwei Wang ,&nbsp;Limeng Yang ,&nbsp;Weibin Du ,&nbsp;Wei Zhuang","doi":"10.1016/j.jpba.2025.116801","DOIUrl":"10.1016/j.jpba.2025.116801","url":null,"abstract":"<div><div>Glucocorticoids (GCs) are widely used, particularly concerning in pediatric patients. GC-induced growth retardation (GIGR) is one of its significant side effects. Endochondral ossification of growth plate chondrocytes is crucial for skeletal growth in children; excessive GCs inhibit growth plate development and longitudinal bone growth. Previous studies have shown that psoralen (PSO) has anti-osteoporotic effects, preserves cartilage homeostasis, and enhances chondrocyte proliferation. However, the specific mechanisms remain unclear. This study used network pharmacology and molecular docking to identify targets, followed by experimental validation to investigate how PSO affects damage to GC-induced growth plate chondrocytes. Results show that the PSO group exhibited significant increases in femoral length and growth plate size compared to the model group in rats. Additionally, testicular weight significantly increased in the PSO group compared to the model group. In vitro experiments demonstrated that PSO enhances proliferation and maintains cellular homeostasis in growth plate chondrocytes. Furthermore, experiments employing Western blotting, immunofluorescence, and other methods confirmed increased PI3K/AKT pathway activity, as well as elevated expression of cartilage-related proteins and reduced apoptotic proteins. Through network pharmacology, molecular docking, and experimental validation, we found that PSO stabilizes growth plate cell homeostasis and promotes cell proliferation by activating the PI3K/AKT signaling pathway. Therefore, PSO may be a potential therapeutic agent for improving GC-induced GIGR.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116801"},"PeriodicalIF":3.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143654673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New insights into the analysis of faradiol esters and related compounds in Calendula","authors":"Benno F. Zimmermann,&nbsp;Esther Häberle","doi":"10.1016/j.jpba.2025.116792","DOIUrl":"10.1016/j.jpba.2025.116792","url":null,"abstract":"<div><div>In this study, the analysis of pentacyclic triterpenediol esters (e.g., faradiol esters) in <em>Calendula officinalis</em> (marigold) flowers by RP-HPLC-UV and RP-UHPLC-UV-MS² is discussed. The removal of carotenoids before HPLC-UV analysis has always been considered essential. However, this study demonstrates that this is unnecessary as the carotenoids do not interfere with the primary faradiol esters and the related compounds in the HPLC-UV chromatogram. Previously identified esters include the laurates, myristates and palmitates of faradiol and of three of its isomers (e.g., arnidiol, maniladiol and calenduladiol). This study tentatively identifies novel butyrates, caproates, caprylates, caprates, stearates, palmitoleates and oleates of faradiol and its isomers. These tentative identifications were performed using UHPLC coupled with triple quadrupole mass spectrometry (MS) through in-source fragments, product ion spectra (MS²) and parent ion spectra. Moreover, the product ion spectra of the faradiol isomers were compared. While similarities exist, some isomers were distinguishable.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116792"},"PeriodicalIF":3.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143687077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The UHPLC-MS/MS method for the determination of 26 synthetic benzimidazole opioids (nitazene analogs) with isomers separation","authors":"Olga Wachełko ,&nbsp;Kaja Tusiewicz ,&nbsp;Paweł Szpot ,&nbsp;Marcin Zawadzki","doi":"10.1016/j.jpba.2025.116796","DOIUrl":"10.1016/j.jpba.2025.116796","url":null,"abstract":"<div><div>The global opioid crisis is a public health emergency characterized by the widespread misuse of opioid drugs, leading to high rates of addiction, overdose, and death. Initially driven by the over-prescription of opioid painkillers, it has evolved into a worldwide epidemic exacerbated by the rise of potent synthetic opioids. Benzimidazole opioids (‘nitazenes’) are one group within this class of compounds that have garnered increasing attention in recent years due to their addictive potential and growing presence in illicit drug markets. Because of their high potency, low concentrations in biological samples are expected, implying the need for very sensitive and selective methods. In the presented paper, an UHPLC-QqQ-MS/MS method was developed for the determination of 26 nitazenes in biological samples (including metabolites), with simultaneous separation of structural isomers. Biological samples were prepared using liquid-liquid extraction (LLE) at pH 9, and quantification was performed using MRM mode. Metonitazene-d₃ was used as the internal standard. Precision and accuracy did not exceed 14.9 % and ± 14.1 %, respectively. Recovery and matrix effect values were 80.6–120.4 % and ± 20.4 %. The method achieved a remarkably low limit of quantification (LOQ), with values of 50 pg/mL for flunitazene and 10 pg/mL for all other compounds. Furthermore, MS/MS (QqQ) spectra were collected for all compounds, enabling the evaluation of fragmentation pathways and characteristic ions for different structural analogs. The knowledge regarding the fragmentation mechanisms of these compounds, along with the ESI-MS spectra provided in this paper, can impact the future identification of newly emerging nitazene analogs.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116796"},"PeriodicalIF":3.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143592040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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 a HPLC-MS/MS method the determination of genistein and equol in serum, urine and follicular fluid","authors":"Xia Zheng ,&nbsp;Yue-jin Wu ,&nbsp;Li-mei Wu ,&nbsp;Ling Zhang ,&nbsp;Lin Zhang ,&nbsp;Zhen Jin ,&nbsp;Fang Gao ,&nbsp;Qing-qing Li ,&nbsp;Yin Wang ,&nbsp;Yi-dan Wu","doi":"10.1016/j.jpba.2025.116800","DOIUrl":"10.1016/j.jpba.2025.116800","url":null,"abstract":"<div><div>Soy isoflavones exert estrogen-like synergistic or antagonistic effects by binding to estrogen receptors, and potentially impact the function of female reproductive system, but their distribution profile in human remains little clarified. To determination of genistein (GEN) and equol (EQ) in human urine, serum and follicular fluid (FF), an analytical method based on high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was developed and validated. The enrichment and clean-up are performed on a solid-phase extraction (SPE) column; the elution is a gradient one, with the mobile phase (A) of 0.1 % (v/v) formic acid aqueous solution and the mobile phase (B) of 0.1 % (v/v) formic acid in acetonitrile; the column temperature is 40 °C. Mass spectrometry is performed using negative ion mode electrospray ionization (ESI -) in multiple reaction monitoring (MRM) mode. The method was validated over the linear ranges of 7.8–1000.0 ng/mL and 39.1–5000.0 ng/mL, for serum and urine, with correlation coefficients (r) of 0.9948–0.9984. The precision, accuracy and stability meet the U.S. Food and Drug Administration guidance. This method has been used to detect genistein (GEN) and equol (EQ) in serum, follicular fluid, and urine, to report equol in follicular fluid for the first time, and to study the correlation between genistein and equol in three body fluids. The study showed that the average concentration of EQ in follicular fluid was 18.5 ng/mL and there was a significant positive Spearman's correlation between concentrations of GEN in serum and FF (r = 0.44, p ≤ 0.05).</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116800"},"PeriodicalIF":3.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143611317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early metabolomics revealed the sensitivity of sacubitril/valsartan to person with end-stage renal disease accompanied by heart failure","authors":"Lili Song ,&nbsp;Jiayi Lin ,&nbsp;Weiyu Yang,&nbsp;Lijuan Zhang,&nbsp;Huimin Liu,&nbsp;Jinxia Wei,&nbsp;Yubo Li","doi":"10.1016/j.jpba.2025.116790","DOIUrl":"10.1016/j.jpba.2025.116790","url":null,"abstract":"<div><div>Heart failure (HF) is a major complication in patients with end-stage renal disease (ESRD) and is the leading cause of death in this high-risk population. Sacubitril/Valsartan is an angiotensin receptor-neprilysin inhibitor (ARNI) that has been shown to improve treatment outcomes in patients with ESRD accompanied by HF. Unfortunately, in clinical practice, some patients who received sacubitril/valsartan treatment not only did not show a good therapeutic effect, but also got worse with the passage of time. To explore potential biomarkers for predicting the clinical efficacy of sacubitril/valsartan, serum samples were prospectively collected upon admission and again collected after sacubitril/valsartan treatment was completed. Patients were divided into good response group (GR) and poor response group (PR). At the same time, samples before treatment were divided into GR group and PR group by sample tracing and matching, and metabolomics analysis was conducted. In the end, a total of 9 different metabolites were identified between patients in the early GR and PR groups. In order to find more effective biomarkers, two algorithms, random forest (RF) and support vector machine (SVM), were used for metabolite selection and performance evaluation, and three kinds of Lysophosphatidylcholine (LysoPC) metabolites showed good predictive effect, and the expression of the enzyme phospholipase A2 group IVA (PLA2G4A), associated with this metabolite was significantly elevated in the PR group. The disordered metabolism may reduce the sensitivity of patients to sacubitril/valsartan treatment, and PLA2G4A targeted inhibitors may be a promising therapeutic strategy to improve the sensitivity of patients with ESRD and HF to sacubitril/valsartan treatment.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116790"},"PeriodicalIF":3.1,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143579668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploration of material basis: Chemical composition profile and metabolic profile in Xiao Jianzhong Granules","authors":"Xuanxuan Zhou ,&nbsp;Jiaxue Wang ,&nbsp;Caihong Li ,&nbsp;Ling Zheng ,&nbsp;Hongjin Wang ,&nbsp;Lixin Sun","doi":"10.1016/j.jpba.2025.116793","DOIUrl":"10.1016/j.jpba.2025.116793","url":null,"abstract":"<div><div>Xiao Jianzhong Granules (XJZG), a well-known traditional prescription with protective effects on the gastric mucosa, as documented in the <em>Treatise on Typhoid and Miscellaneous Diseases</em>. Clinical studies have proven that XJZG exhibits significant anti-colitis properties and effectively alleviates duodenal ulcers. However, despite its clinical popularity, comprehensive studies on its chemical composition and <em>in vivo</em> metabolism remain limited. In the present study, gas chromatography coupled with mass spectrometry (GC-MS) and ultra-high-performance liquid chromatography coupled with Q-Exactive Orbitrap mass spectrometry (UHPLC Q-Exactive Orbitrap MS) were used to analyze the chemical composition of XJZG, while it is <em>in vivo</em> metabolic profile was further assessed with UHPLC Q-Exactive Orbitrap MS. Additionally, ultra-high-performance liquid chromatography coupled with triple quadrupole mass spectrometry (UHPLC-MS/MS) was utilized to quantify its primary components. As a result, a total of 51 volatiles were characterized by GC–MS, and 139 compounds were characterized by UHPLC Q-Exactive Orbitrap MS <em>in vitro</em>. In addition, 51 prototype components and 133 metabolites were characterized <em>in vivo</em>. Notably, 5 new compounds were discovered in this process. The main metabolic reactions included oxidation, reduction, hydrolysis, glucuronidation, and sulfate esterification. In quantitative analysis, 17 components were determined and successfully applied for detection by UPLC-MS/MS in multiple reaction monitoring mode. The quantitative methods were validated and met the requirements. Through multivariate statistical analysis, 6 components were selected as potential quality markers for XJZG based on PCA and OPLS-DA. Additionally, our study provides supplementary chemical evidence to further elucidate the material basis of XJZG.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116793"},"PeriodicalIF":3.1,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143592042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Considerations regarding the selection, sampling, extraction, analysis, and modelling of biomarkers in exhaled breath for early lung cancer screening","authors":"Robert Lundberg ,&nbsp;Johan Dahlén ,&nbsp;Thomas Lundeberg","doi":"10.1016/j.jpba.2025.116787","DOIUrl":"10.1016/j.jpba.2025.116787","url":null,"abstract":"<div><div>Lung cancer (LC) is the deadliest cancer due to the lack of efficient screening methods that detect the disease early. This review, covering the years 2011 – 2025, summarizes state-of-the-art LC screening through analysis of volatile organic compounds (VOCs) in exhaled breath. All fundamental parts of the methodology are covered, i.e., sampling, analysis, and multivariate data modelling. This review shows that breath is commonly collected in Tedlar® bags and subsequently analysed with solid phase micro-extraction gas chromatography mass spectrometry (SPME-GC-MS) or sensors. Data analysis has been made using multivariate methods like principal component analysis (PCA) or artificial neural networks (ANNs). The VOCs exhaled by LC patients and healthy subjects are in principle the same. However, concentration levels differ between the two groups. Therefore, LC patients are usually separated from healthy controls through multivariate modelling of a set of VOC biomarkers rather than by individual biomarkers. Although most exhaled VOCs are formed endogenously via metabolic processes and oxidative stress, some compounds also have exogenous origins, which must be taken into consideration. More than 200 different VOCs have been reported as potential biomarkers in the breath of LC patients, while the number of biomarkers per study were typically around 10–20 compounds. The 15 most common LC biomarkers were (from high to low frequency) acetone, isoprene, hexanal, benzene, butanone, styrene, ethylbenzene, 1-propanol, 2-propanol, toluene, pentanal, 2-pentanone, cyclohexane, nonanal and decane. Several methods showed, in combination with multivariate data analysis, potential to distinguish between LC patients and healthy controls.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116787"},"PeriodicalIF":3.1,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143549086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HPLC method for detecting prostaglandin F2α analogs in cosmetics: Optimization for chromatographic separation and sample preparation","authors":"Kyoung-Moon Han ,&nbsp;In Suk Woo ,&nbsp;You Kyung Kim,&nbsp;Eun Jin Shin,&nbsp;Min Kyung Sung,&nbsp;Hyung Soo Kim,&nbsp;Hyun-Kyung Kim","doi":"10.1016/j.jpba.2025.116788","DOIUrl":"10.1016/j.jpba.2025.116788","url":null,"abstract":"<div><div>Some prostaglandin F_2α (PGF_2α) analogs, including bimatoprost and tafluprost, are pharmaceutical substances known to cause specific abnormal reactions that promote eyelash growth. However, research on the simultaneous analysis of multiple PGF_2α analogs using HPLC–UV or DAD techniques is limited. In this study, a high-performance liquid chromatography (HPLC) method was developed for the simultaneous analysis of 11 PGF_2α analogs, optimizing both the analytical column and sample preparation method. Five columns with varying particle sizes, lengths, and packing types were compared to select the optimal analytical column. The separation efficiency of the columns was confirmed by comparing their chromatographic parameters, including retention time, resolution, number of theoretical plates, and height equivalent to a theoretical plate. Solid-phase extraction (SPE) was used to pretreat cosmetic samples, and the washing solvent and cartridge type for the SPE process were optimized. The established HPLC method was validated in terms of linearity, limits of detection and quantification, recovery, accuracy, and precision. The verified analytical method was applied to eyelash serums currently available in the market, and norbimatoprost was detected in one product. The HPLC method proposed in this study may help prevent the distribution of cosmetics containing illegal PGF_2α analogs.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116788"},"PeriodicalIF":3.1,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143579666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unveiling the effect of chemical degradation on cyclic lipoglycopeptide Oritavancin using Orbitrap mass spectrometry","authors":"Sree Teja Paritala,&nbsp;Gunjan Gandhi,&nbsp;Jayesh Dongare,&nbsp;Nitish Sharma","doi":"10.1016/j.jpba.2025.116745","DOIUrl":"10.1016/j.jpba.2025.116745","url":null,"abstract":"<div><div>Oritavancin is the second-generation approved semisynthetic cyclic lipoglycopeptide by the United States Food and Drug Administration (USFDA) for acute bacterial skin and skin-structure infections which serves as a last resort of treatment. Unlike other lipoglycopeptides, the stability behavior of Oritavancin was least explored, which is a prerequisite. The current study endeavors to elucidate the oxidative, hydrolytic, thermal and photolytic stability behavior of Oritavancin by exposing the drug to respective stress conditions. A simple liquid chromatography (LC) method was developed, where significant resolution between Oritavancin and the generated degradation products was achieved. In total 13 degradation products were identified under various stress conditions. Using LC-HRMS, MS/MS studies, the generated degradation products were identified and characterized. The intact mass for DP-2,7,12 was <em>m/z</em> 724.7219(2), DP-6,11, 13 was <em>m/z</em> 796.2672(2), DP-3,10 was <em>m/z</em> 643.6953(2)<strong>.</strong> However isomeric mass as of ORT intact form was seen for DP-4 and unique masses were identified for DP-1,4,8,10 with <em>m/z</em> 725.4293(2), <em>m/z</em> 905.2965(2), <em>m/z</em> 863.2896(2), <em>m/z</em> 904.2890(2) respectively. The mechanistic fragmentation pathway for all the generated DP's were established and the plausible structure for the identified DP's were postulated based on the MS/MS data. According to the findings, Oritavancin is highly susceptible to photolytic, thermal and hydrolytic condition and least susceptible under oxidative condition. The developed reversed-phase high-performance liquid chromatographic (RP-HPLC) method was validated in accordance with ICH guidelines for Oritavancin using C₁₈ analytical reverse-phase column which could be utilised for routine quality control and therapeutic drug monitoring of Oritavancin.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"260 ","pages":"Article 116745"},"PeriodicalIF":3.1,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143610715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}