Abstract

A COMPREHENSIVE REVIEW ON STABILITY INDICATING METHOD DEVELOPMENT USING UHPLC

Tejaswini R. Patil*, Vedashri G. Patil, Sunil P. Pawar, Mansi A. Dhankani and Amitkumar R. Dhankani

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Abstract

Stability indicating methods (SIMs) are critical in the pharmaceutical industry to ensure the quality, safety, and effectiveness of drug products. Due to its improved speed, resolution, and sensitivity, the development of these methods on ultra-high performance liquid chromatography (UHPLC) platforms has attracted a lot of attention. The goal of the stability indicating approach is to resolve all of the main degradants and any probable process-related contaminants by achieving the right mass balance during the forced degradation. Stability indicating method is capable to measure the active substance and all its degradation products unequivocally in presence of excipients present in the respective formulation. The power of any stability indicating analytical method is to be proved in stress study by identifying its degradation products which in turn establishes the innate stability of the molecule and its degradation pathways. This review aims to provide an in-depth analysis of the latest advances and challenges encountered in the development of stability indicating methods using UHPLC.

Keywords: Stability indicating method, UHPLC, degradation products, validation, pharmaceutical analysis.