LC-MS和NMR对维达列汀片及其原料降解产物的鉴定、分离及其降解途径的探索

Q3 Pharmacology, Toxicology and Pharmaceutics

Jordan Journal of Pharmaceutical Sciences Pub Date : 2023-07-24 DOI:10.35516/jjps.v16i2.1535

Enas Alqudah, Malak Abbadi, Sawsan Alqadoomi, Ibtihal Abo Hameda, S. Arar, K. Sweidan

{"title":"LC-MS和NMR对维达列汀片及其原料降解产物的鉴定、分离及其降解途径的探索","authors":"Enas Alqudah, Malak Abbadi, Sawsan Alqadoomi, Ibtihal Abo Hameda, S. Arar, K. Sweidan","doi":"10.35516/jjps.v16i2.1535","DOIUrl":null,"url":null,"abstract":"A gradient high performance liquid chromatography (HPLC) method has been developed for the qualitative and quantitative analyses of vildagliptin related substances. This method is based on using of RP-C18 (250 × 4.6 mm×5µm) and gradient elution with phosphate buffer and methanol as mobile phase. Various forced degradation studies were conducted to establish an impurity profile for vildagliptin in the tablet formula. Three degradation products were produced upon exposing vildagliptin to different degradation conditions (acidic, basic, oxidative, photolytic, aqueous and thermal); their structures were characterized using LC-MS and NMR (1H NMR, 13C NMR and DEPT) techniques. Some excipient components, examined in this study, had major effect towards producing any extra new degradation products.","PeriodicalId":14719,"journal":{"name":"Jordan Journal of Pharmaceutical Sciences","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Identification and Separation of the Degradation Products of Vildagliptin Tablets and Raw Material using LC-MS and NMR, and then Exploration of the Corresponding Degradation Pathways\",\"authors\":\"Enas Alqudah, Malak Abbadi, Sawsan Alqadoomi, Ibtihal Abo Hameda, S. Arar, K. Sweidan\",\"doi\":\"10.35516/jjps.v16i2.1535\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A gradient high performance liquid chromatography (HPLC) method has been developed for the qualitative and quantitative analyses of vildagliptin related substances. This method is based on using of RP-C18 (250 × 4.6 mm×5µm) and gradient elution with phosphate buffer and methanol as mobile phase. Various forced degradation studies were conducted to establish an impurity profile for vildagliptin in the tablet formula. Three degradation products were produced upon exposing vildagliptin to different degradation conditions (acidic, basic, oxidative, photolytic, aqueous and thermal); their structures were characterized using LC-MS and NMR (1H NMR, 13C NMR and DEPT) techniques. Some excipient components, examined in this study, had major effect towards producing any extra new degradation products.\",\"PeriodicalId\":14719,\"journal\":{\"name\":\"Jordan Journal of Pharmaceutical Sciences\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-07-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Jordan Journal of Pharmaceutical Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.35516/jjps.v16i2.1535\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Jordan Journal of Pharmaceutical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.35516/jjps.v16i2.1535","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}

引用次数: 0

摘要

建立了一种梯度高效液相色谱法（HPLC）对维达列汀相关物质进行定性和定量分析。该方法以RP-C18（250×4.6mm×5µm）为流动相，以磷酸盐缓冲液和甲醇为流动相进行梯度洗脱。进行了各种强制降解研究，以确定片剂配方中维达格利汀的杂质分布。维达格列汀暴露于不同的降解条件（酸性、碱性、氧化性、光解性、水性和热性）后，产生了三种降解产物；使用LC-MS和NMR（1H NMR、13C NMR和DEPT）技术表征它们的结构。本研究中检查的一些赋形剂成分对产生任何额外的新降解产物具有主要影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Identification and Separation of the Degradation Products of Vildagliptin Tablets and Raw Material using LC-MS and NMR, and then Exploration of the Corresponding Degradation Pathways

A gradient high performance liquid chromatography (HPLC) method has been developed for the qualitative and quantitative analyses of vildagliptin related substances. This method is based on using of RP-C18 (250 × 4.6 mm×5µm) and gradient elution with phosphate buffer and methanol as mobile phase. Various forced degradation studies were conducted to establish an impurity profile for vildagliptin in the tablet formula. Three degradation products were produced upon exposing vildagliptin to different degradation conditions (acidic, basic, oxidative, photolytic, aqueous and thermal); their structures were characterized using LC-MS and NMR (1H NMR, 13C NMR and DEPT) techniques. Some excipient components, examined in this study, had major effect towards producing any extra new degradation products.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Jordan Journal of Pharmaceutical Sciences Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

1.70

自引率

0.00%

发文量

期刊介绍： The Jordan Journal of Pharmaceutical Sciences (JJPS) is a scientific, bi-annual, peer-reviewed publication that will focus on current topics of interest to the pharmaceutical community at large. Although the JJPS is intended to be of interest to pharmaceutical scientists, other healthy workers, and manufacturing processors will also find it most interesting and informative. Papers will cover basic pharmaceutical and applied research, scientific commentaries, as well as views, reviews. Topics on products will include manufacturing process, quality control, pharmaceutical engineering, pharmaceutical technology, and philosophies on all aspects of pharmaceutical sciences. The editorial advisory board would like to place an emphasis on new and innovative methods, technologies, and techniques for the pharmaceutical industry. The reader will find a broad range of important topics in this first issue.