{"title":"新型抗糖尿病药物依格列汀稳定性指示液相色谱测定方法的建立","authors":"Deepanti Gajjar, Dimalkumar S. Shah","doi":"10.1002/sscp.202300082","DOIUrl":null,"url":null,"abstract":"Abstract Evogliptin (EVG) is prescribed in the treatment of type 2 diabetes. An accurate and precise high‐performance liquid chromatographic method along with forced degradation studies and design of experiments has been developed for the estimation of EVG. Agilent C 18 Column (250 × 4.6 mm, 5 μm particle size) was used as the stationary phase and methanol: 0.05% Orthophosphoric acid in water (51: 49% V/V) was used as the mobile phase. The method was linear in the concentration range of 5–30 μg/ml with a correlation coefficient (r 2 ) of 0.9996. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per the International Conference on Harmonization Q2 (R1) guideline. A forced degradation study was performed to find out the intrinsic stability of the molecules. The degradation products were well resolved from the drug peak and did not interfere with the analysis. The method was successfully applied for the analysis of EVG.","PeriodicalId":21639,"journal":{"name":"SEPARATION SCIENCE PLUS","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2023-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development of stability indicating liquid chromatographic method for estimation of novel anti‐diabetic drug Evogliptin\",\"authors\":\"Deepanti Gajjar, Dimalkumar S. Shah\",\"doi\":\"10.1002/sscp.202300082\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract Evogliptin (EVG) is prescribed in the treatment of type 2 diabetes. An accurate and precise high‐performance liquid chromatographic method along with forced degradation studies and design of experiments has been developed for the estimation of EVG. Agilent C 18 Column (250 × 4.6 mm, 5 μm particle size) was used as the stationary phase and methanol: 0.05% Orthophosphoric acid in water (51: 49% V/V) was used as the mobile phase. The method was linear in the concentration range of 5–30 μg/ml with a correlation coefficient (r 2 ) of 0.9996. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per the International Conference on Harmonization Q2 (R1) guideline. A forced degradation study was performed to find out the intrinsic stability of the molecules. The degradation products were well resolved from the drug peak and did not interfere with the analysis. The method was successfully applied for the analysis of EVG.\",\"PeriodicalId\":21639,\"journal\":{\"name\":\"SEPARATION SCIENCE PLUS\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2023-09-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"SEPARATION SCIENCE PLUS\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/sscp.202300082\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"SEPARATION SCIENCE PLUS","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/sscp.202300082","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
引用次数: 0
摘要
EVG是治疗2型糖尿病的处方药。通过强制降解研究和实验设计,开发了一种准确、精确的高效液相色谱法来估计EVG。以Agilent C 18色谱柱(250 × 4.6 mm, 5 μm粒径)为固定相,甲醇:0.05%正磷酸水溶液(51∶49% V/V)为流动相。该方法在5 ~ 30 μg/ml浓度范围内线性良好,相关系数(r2)为0.9996。根据国际协调会议Q2 (R1)指南,对所提出的方法进行了线性,准确度,精密度和鲁棒性验证。进行了强制降解研究,以找出分子的内在稳定性。降解产物从药峰上很好地分离出来,不干扰分析。该方法成功地应用于EVG的分析。
Development of stability indicating liquid chromatographic method for estimation of novel anti‐diabetic drug Evogliptin
Abstract Evogliptin (EVG) is prescribed in the treatment of type 2 diabetes. An accurate and precise high‐performance liquid chromatographic method along with forced degradation studies and design of experiments has been developed for the estimation of EVG. Agilent C 18 Column (250 × 4.6 mm, 5 μm particle size) was used as the stationary phase and methanol: 0.05% Orthophosphoric acid in water (51: 49% V/V) was used as the mobile phase. The method was linear in the concentration range of 5–30 μg/ml with a correlation coefficient (r 2 ) of 0.9996. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per the International Conference on Harmonization Q2 (R1) guideline. A forced degradation study was performed to find out the intrinsic stability of the molecules. The degradation products were well resolved from the drug peak and did not interfere with the analysis. The method was successfully applied for the analysis of EVG.