Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
The stability indicating assay is a method used in the pharmaceutical industry to analyze stability samples. It is crucial to validate the assay for precision, accuracy, reproducibility, selectivity, and robustness. Current guidelines for stability testing of drug substances and products require stress testing or forced degradation studies to be conducted for stability indicating assays. However, these guidelines do not specify how these studies should emphasize testing features susceptible to change during storage, which can affect quality, safety, and efficacy. Therefore, validated stability indicating testing methods must be used. Stability indicating analytical methods are well-established for active pharmaceutical ingredients, ensuring that allopathic medicines meet quality standards despite product degradation. Given the need for stability indicating analytical methods in herbal medicine, this study aims to apply and validate an HPTLC method for detecting forced degradation products of Solifenacin.