European Journal of Biomedical and Pharmaceutical Sciences

COMPLETE PRACTICAL WAY OF STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION BY HPLC FOR DRUG SUBSTANCE AS WELL AS THE PRODUCT: A REVIEW

Manoj Kumar Vadlamudi and Sangeetha Dhanaraj*

ABSTRACT

Analytical method should be developed as stability indicating and validate to provide reliable data for regulatory submissions. Analytical method is establishing evidence that provides a high degree of assurance and is an important process in the drug discovery. Even though the drug shows good potency, lack of a validated analytical method will not allow the drug to enter into regular analysis as well as in the market. This review covers the importance/practical way of development, forced degradation and validates stability indicating analytical method and their strategies along with brief knowledge of analytical chromatographic parameters needs to be optimized of an effective method development for drug substance as well as product.

Keywords: Analytical method validation, force degradation, drug substance, drug product, chromatographic parameters.