Issue |
Wuhan Univ. J. Nat. Sci.
Volume 28, Number 4, August 2023
|
|
---|---|---|
Page(s) | 333 - 340 | |
DOI | https://doi.org/10.1051/wujns/2023284333 | |
Published online | 06 September 2023 |
Chemistry
CLC number: R917
Simultaneous Analysis of Indapamide and Related Impurities in Sustained-Release Tablets by a Single-Run HPLC-PDA Method
1
College of Chemistry and Chemical Engineering, Huangshan University, Huangshan 245000, Anhui, China
2
Huangshan Zhonghuang Pharmaceutical Co., Ltd., Huangshan 245000, Anhui, China
Received:
11
January
2023
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 0.028-1.80 μg/mL (R=0.999 95), 0.060-1.20 μg/mL (R=0.999 6), 0.032 4-1.20 μg/mL (R=0.999 85) and 0.060-1.20 μg/mL (R=0.999 7) with detection limits of 0.009 3, 0.012, 0.012 and 0.006 μg/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.
Key words: indapamide / related impurity / sustained-release tablets / high performance liquid chromatography equipped with photodiode array detector (HPLC-PDA)
Biography: YAO Wu, male, Professor, research direction: analytical chemistry and pharmaceutical analysis. E-mail: yaowu92@sohu.com
Fundation item: Supported by 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)
© Wuhan University 2023
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