Abstract

STABILITY INDICATING METHOD DEVELOPMENT FOR DRUG STABILIZATION: A REVIEW

Annapurna S. Gupta*, Uday Deokate, Sanjay Vasave and Priya Mijgar

ABSTRACT

The regulatory issues of stability indicating method development are reviewed in this work. The API is distinguished from any potential breakdown products using SIMs. Validated stability indicating methods are required by regulatory guidance in ICH Q1A (R2), ICH Q3B (R2), Q6A, and FDA 21 CFR section 211. To establish whether the analytical approach indicates stability, force degradation of drug standard and excipients is conducted under various situations by the help of HPTLC, HPLC with UV, and MS. Forced degradation studies give information regarding crucial degradation pathways and active ingredient degradation products, as well as aid in elucidating the structure of the degradants There is discussion of the methods for developing a stability indicating method by various instrumentation techniques.

Keywords: Stability Indicating Method, UV Spectroscopy, forced Degradation Studies, Method Validation.