::INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES::

CODEN : IAJPBB
issn 2349-7750

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TITLE:

DEVELOPMENT, VALIDATION AND STABILITY INDICATING HPLC METHOD: AN OVERVIEW

AUTHORS:

A. R. Pathade, V. C. Gurumukhi, S. S. Chalikwar, Kanchan R. Patil

ABSTRACT:

The objective of this overview is coverage of development of RP-HPLC method, its validation and evaluation of stability indicating method. .Here, short comings of reported HPLC methods with respect to regulatory aspects was highlighted. Stability-indicating assay method (SIAM) was used to differentiate the API from its potential decomposition product. Regulatory guidance status in ICH Q1A (R2), ICH Q3B (R2), Q6A, and FDA 21 CFR section 211 requires validated stability indicating methods. Force degradation of drug is required to demonstrate the specificity when developing SIAMs. For this purpose, the stability indicating methods was adopted. Force degradation of drug standard and drug product is carried out under different conditions to determine the analytical method was robust Here, the separation of all degradation products, establishment of mass balance, stress testing of drug product, development of SIAMs for combination products, etc. was also addressed. Systematic approaches for the development of stability indicating methods are discussed. Keywords: HPLC; Stability Indicating Method; Analytical Development; Validation.