Research Article
A Validated RP-HPLC Stability Method for the Estimation of Chlorthalidone and Its Process-Related Impurities in an API and Tablet Formulation
| | Name | Structure | IUPAC | Specification limits |
| | Impurities listed in European pharmacopoeia | | Impurity B | | 2-(4-Chloro-3-sulfamoylbenzoyl) benzoic acid. | Not more than 0.7% | | Impurity G | | (3RS)-3-(3-Dichlorophenyl)-3-hydroxy-2,3-dihydro-1H-isoindol-1-one | Not more than 0.2% | | Impurity J | It is a specified but unidentified impurity that elutes at RRT 0.9 with reference to chlorthalidone | Not more than 0.3% | | In-house process-related impurities | | Intermediate stage II | | 3-(4-Chlorophenyl) isoindolin-1-one | Not more than 0.15% | | Intermediate stage III | | 3-(4-Chlorophenyl)-5-sulfonamide isoindoline -1-one | Not more than 0.15% |
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