Simultaneous Analysis of Indapamide and Related Impurities in Sustained-Release Tablets by a Single-Run HPLC-PDA Method  

作　　者：YAO Wu ZHOU Shiwen CHENG Qiongru 

机构地区：[1]College of Chemistry and Chemical Engineering,Huangshan University,Huangshan 245000,Anhui,China [2]Huangshan Zhonghuang Pharmaceutical Co.,Ltd.,Huangshan 245000,Anhui,China

出　　处：《Wuhan University Journal of Natural Sciences》2023年第4期333-340,共8页武汉大学学报（自然科学英文版）

基　　金：the Natural Science Foundation of Anhui Province,China(11040606M41);the Natural Science Project in Colleges and Universities of Anhui Province,China(kj2016A683);the Natural Science Project of Huangshan University,China(hxkt20190042,xdhz202007)。

摘　　要：The contents of indapamide and related impurities in generic indapamide sustained-release tablets were simultaneously detected by a single-run high performance liquid chromatography equipped with photodiode array detector(HPLC-PDA)method for the quality control in this paper.The results showed the method had a good selectivity and was validated through linearity,limits of detection and quantification,recovery,and precision.The linear ranges of indapamide,2-methyl-1-nitroso-2,3-dihydro-1H-indole(impurity A,ImA),4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoyl-benzamide(impurity B,ImB)and 4-chloro-3-sulfamoylbenzoic acid(impurity 1,Im1)were 0.028-1.80μg/mL(R=0.99995),0.060-1.20μg/mL(R=0.9996),0.0324-1.20μg/mL(R=0.99985)and 0.060-1.20μg/mL(R=0.9997)with detection limits of 0.0093,0.012,0.012 and 0.006μg/mL,respectively.ImA and Im1 were not detectable in the generic drug.The content of indapamide was 96.7%of the labeled amount with a relative standard deviation(RSD)of 1.30%,and the percentage of ImB relative to the labeled amounts of indapamide was 0.106%with an RSD of 1.82%.The content of other unspecified impurities all met the reference quality standards.The results provided references for the quality control and the quality standard study of generic indapamide sustained-release tablets.

关 键 词：INDAPAMIDE related impurity sustained-release tablets high performance liquid chromatography equipped with photodiode array detector(HPLC-PDA) 

分 类 号：R917[医药卫生—药物分析学]