STABILITY INDICATING HPTLC METHOD FOR THE ESTIMATION OF MIRABEGRON

Abstract

In the pharmaceutical sector, a stability-indicating assay plays a critical role in analyzing samples for stability. Validation of such assays is essential to ensure precision, accuracy, reproducibility, selectivity, and robustness. Current guidelines for stability testing of drug substances and products mandate stress testing or forced degradation studies to validate stability-indicating assays. However, these guidelines do not specify how such studies should emphasize testing features prone to changes during storage, potentially affecting quality, safety, and efficacy.

Stability-indicating analytical methods are extensively utilized for active pharmaceutical ingredients, ensuring that allopathic medicines meet stringent quality standards even after prolonged storage and potential degradation. Recognizing the necessity for similar stability-indicating methods in herbal medicine, this study focuses on applying a developed and validated HPTLC method to detect products of forced degradation in Mirabegron.