Journal of chromatographic science最新文献_第7页

Structural Elucidation of Novel Degradation Impurities of Ibrutinib in Ibrutinib Tablets Using Preparative Chromatography, LCMS, HRMS and 2D NMR Techniques. 利用制备色谱、LCMS、HRMS 和 2D NMR 技术阐明伊布替尼片中伊布替尼新型降解杂质的结构。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2024-02-09 DOI: 10.1093/chromsci/bmae002

Rajender Reddy Yerla, Surendrababu Manubolusurya, Saravanakumar Meganathan, Veerababu Madalapu, Gopal Vaidyanathan

{"title":"Structural Elucidation of Novel Degradation Impurities of Ibrutinib in Ibrutinib Tablets Using Preparative Chromatography, LCMS, HRMS and 2D NMR Techniques.","authors":"Rajender Reddy Yerla, Surendrababu Manubolusurya, Saravanakumar Meganathan, Veerababu Madalapu, Gopal Vaidyanathan","doi":"10.1093/chromsci/bmae002","DOIUrl":"https://doi.org/10.1093/chromsci/bmae002","url":null,"abstract":"Ibrutinib is an orally administered compound that functions as an irreversible covalent inhibitor of the Bruton tyrosine kinase, an essential element in multiple cellular processes including B-cell differentiation, proliferation, migration, survival and apoptosis. The compound has been found to demonstrate efficacy against a range of B-cell malignancies. The drug product is available in oral tablet and capsule formulations. The drug degradation profiles of tablets dosage form were assessed in accordance with regulatory guidelines. The results indicate that the drug substance is susceptible to alkaline and oxidative stress. The oxidation degradation led to the identification of three significant unknown degradation impurities. The three compounds were isolated through the application of preparative liquid chromatography, and their structures were determined using analytical techniques such as liquid chromatography-mass spectrometry, high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy. Utilizing structural elucidation data, predictions were made regarding the composition of impurities, revealing them to be novel degradation impurities that bear structural resemblance to ibrutinib. Additionally, potential pathways for the formation of the impurities were proposed.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139712296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Derivatization-Based Novel Chromatographic and Spectrophotometric Methods for the Simultaneous Determination of Gymnemic Acid and Resveratrol in Antidiabetic Polyherbal Formulation. 基于衍生化的新型色谱和分光光度法同时测定抗糖尿病复方中药制剂中裸子酸和白藜芦醇的含量。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2024-02-02 DOI: 10.1093/chromsci/bmad084

Dhruv Joshi, Charmy Kothari, Nrupesh Patel

{"title":"Derivatization-Based Novel Chromatographic and Spectrophotometric Methods for the Simultaneous Determination of Gymnemic Acid and Resveratrol in Antidiabetic Polyherbal Formulation.","authors":"Dhruv Joshi, Charmy Kothari, Nrupesh Patel","doi":"10.1093/chromsci/bmad084","DOIUrl":"10.1093/chromsci/bmad084","url":null,"abstract":"Herbal medicine is widely used for the treatment and prevention of various ailments, highlighting the importance of ensuring its consistency and quality. This research focuses on the simultaneous detection of Gymnemic acid (GYM) and Resveratrol (RES) in an antidiabetic polyherbal formulation as no reported method exists for their simultaneously detection. The objective of this study is to develop and validate novel derivatization-based spectrometric and HPTLC methods for the simultaneous determination of GYM and RES. The spectrophotometric method involved derivatization of GYM with benzoyl chloride, followed by measurement of absorbance at 349 nm an isoabsorptive point. The HPTLC method utilized post derivatization with vanillin-sulfuric acid, and its separation was achieved on pre-coated silica gel 60GF254 using chloroform:methanol:glacial acetic acid (13:4:0.1, v/v/v) as mobile phase and estimated at 575 nm. The developed method exhibits linearity, accuracy, precision, LOD, LOQ, specificity and robustness in accordance with the ICH Q2 (R1) guideline. The percent assay of GYM and RES in the marketed capsule formulation was statistically compared using an unpaired t-test, resulting in a range of 99.51-102.65%. These indicate no significant difference between the proposed method and the marketed formulation. Therefore, both novel methods can be interchangeably used for quality control of GYM and RES in polyherbal formulations.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"107591425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Study of Pharmacokinetics for Ivermectin B1a from Beagle Dogs. 比格犬伊维菌素 B1a 的药代动力学研究

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2023-12-21 DOI: 10.1093/chromsci/bmad092

Yuyang Chen, Xiaofang Huang, Zizheng Guo, Jingyu Zhang, Lixin Zhang, Renke Dai

{"title":"Study of Pharmacokinetics for Ivermectin B1a from Beagle Dogs.","authors":"Yuyang Chen, Xiaofang Huang, Zizheng Guo, Jingyu Zhang, Lixin Zhang, Renke Dai","doi":"10.1093/chromsci/bmad092","DOIUrl":"https://doi.org/10.1093/chromsci/bmad092","url":null,"abstract":"Ivermectin has been widely used for antiparasitic drug, and has recently shown a broad-spectrum antiviral activity, including anti-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, the pharmacokinetic property of ivermectin has not been fully investigated yet. During the plasma preparation, ~32-46% of ivermectin was found in the precipitation. An Liquid Chromatograph-Mass Spectrometer (LC-MS/MS) method for ivermectin in the whole blood samples from beagle dogs was developed and validated. The specificity, accuracy, precision (intra-day and inter-day), matrix effect, recovery and stability of analyte reported here are satisfied with the criteria of Food and Drug Administration (FDA)-Bioanalysis guideline. The oral administrations pharmacokinetics of ivermectin in beagle dogs under fasting and after high-fat meal were studied, and the following parameters were obtained: fasting Cmax, 104 ± 35 μg·L-1; area under the concentration-time curve (AUC0-∞), 2,555 ± 941 h·μg·L-1; and high-fat meal Cmax, 147 ± 35 μg·L-1; AUC0-∞, 4,198 ± 1,279 h·μg·L-1. When the P-gp inhibitor curcumin was also coadministrated orally, Cmax and AUC0-∞ were found to be 177 ± 57 and 4,213 ± 948 h·μg·L-1, respectively. With the comparison to fasting treatment, coadministration of P-gp inhibitor curcumin resulted in increase of the exposure of ivermectin by 1.6-fold, while the exposure after the high-fat diet versus fasting was increased approximately in 1.4-fold, indicating that alternative absorption might play an important role for increasing the exposure of ivermectin for future clinic applications.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138885095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Characterization of the Chemical Constituents in Radix gentianae by Ultra-High Performance Liquid Chromatography Coupled with Quadrupole Time-of-Flight Mass Spectrometry 超高效液相色谱-四极杆飞行时间质谱法表征龙胆草中的化学成分

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2023-12-20 DOI: 10.1093/chromsci/bmad091

Xu Pan, Jiao Guan, Yue Cui, Lele Li, Xiaoying Lin, Bo Feng, Heyun Zhu

引用次数: 0

Bioanalytical Method Development and Validation of Doxorubicin and Lapatinib in Rat Plasma Using UHPLC-HESI-LTQ-MS. 利用 UHPLC-HESI-LTQ-MS 对大鼠血浆中多柔比星和拉帕替尼的生物分析方法进行开发和验证

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2023-12-12 DOI: 10.1093/chromsci/bmad090

Shaik Khaja Moinuddin, Pirangi Srikanth, Parul Sharma, Sukhendu Nandi

{"title":"Bioanalytical Method Development and Validation of Doxorubicin and Lapatinib in Rat Plasma Using UHPLC-HESI-LTQ-MS.","authors":"Shaik Khaja Moinuddin, Pirangi Srikanth, Parul Sharma, Sukhendu Nandi","doi":"10.1093/chromsci/bmad090","DOIUrl":"https://doi.org/10.1093/chromsci/bmad090","url":null,"abstract":"Cancer is considered a silent killer. The complexity of cancer makes it earn that title. So far there are only a few approaches to treat cancer. Among them, chemotherapy is considered the best approach. Many chemotherapeutical compounds are commercially available in the market. Among them, doxorubicin (DOX) and lapatinib (LAP) are considered blockbuster molecules. However, DOX suffers from poor bioavailability and exhibits cardiotoxicity. Interestingly, a fixed dose combination of DOX and LAP significantly decreases the cardiotoxic effect of DOX. To enhance the oral bioavailability of DOX and to avail the synergistic effect of LAP, many formulations have been made. To quantify both compounds in any formulation or biological matrix, an Liquid chromatography-Mass Spectrometry (LC-MS) method is required. In this present study, a simple and rapid Ultra High-Performance Liquid Chromatography - Heated Electron Spray Ionization - Mass Spectrometry (UHPLC-HESI-MS) bioanalytical method was developed. The developed method was validated as per the regulatory guidelines. The validated bioanalytical method had a lower limit of quantification of 0.75 ng. A simple protein precipitation technique was optimized to extract the compounds from the rat plasma. All the validation parameters were found to be within the limits as per the regulatory guidelines. A novel and rapid analytical method was successfully developed and validated. This developed method can be used to quantify the DOX and LAP in any formulation and biological matrix.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2023-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138804829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Verifying the Equivalence of Hawthorn Leaves Standard Decoction and Formula Granules by LC-MS and Oxidative Stress Test. 用LC-MS和氧化应激试验验证山楂叶标准汤和配方颗粒的等效性。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2023-12-04 DOI: 10.1093/chromsci/bmad089

Ling-Di Wang, Jing-Yun Gao, Li-Ying Duan, Hai-Feng Pan

{"title":"Verifying the Equivalence of Hawthorn Leaves Standard Decoction and Formula Granules by LC-MS and Oxidative Stress Test.","authors":"Ling-Di Wang, Jing-Yun Gao, Li-Ying Duan, Hai-Feng Pan","doi":"10.1093/chromsci/bmad089","DOIUrl":"https://doi.org/10.1093/chromsci/bmad089","url":null,"abstract":"Objective: To verify the equivalence of hawthorn leaves standard decoction and formula granules.Methods: In this experiment, liquid chromatograph mass spectrometer (LC-MS) was used to examine the chemical composition of hawthorn leaves standard decoction and formula granules, separately. In addition, oxidative stress test was used to explore the antioxidant capacity of them.Results: 71 chemical components were identified by LC-MS. Among them, 64 and 56 compounds were identified in the standard decoction and formula granules, respectively. There were a total of 49 common components, with no significant difference in content. Oxidative stress test showed that hawthorn leaves standard decoction and formula granules had no obvious toxicity to human umbilical vein endothelial cells. Compared with the model group, the same dose of hawthorn leaves formula granule and standard decoction could inhibit the secretion of lactate dehydrogenase and malondialdehyde (P < 0.05), and increase the content of superoxide dismutase (P < 0.01), with no statistically significant difference.Conclusions: There is no significant difference in the main active ingredients between the standard decoction and the formula granules, and the antioxidant activity in vitro is equivalent, providing an important theoretical basis for the further development of hawthorn leaves formula granules.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2023-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138482424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0