Abstract

DEVELOPMENT AND VALIDATION OF SOME CLASSICAL AND NOVEL SPECTROPHOTOMETRIC METHODS AND RP-HPLC METHOD BY QbD APPROACH FOR SIMULTANEOUS ESTIMATION OF ARIPIPRAZOLE AND CLOZAPINE IN SYNTHETIC MIXTURE

Ekta Atodaria and Rajashree Mashru*

Abstract

The present study portrays a simple, rapid, sensitive, accurate, precise and cost effective UV Spectrophotometric methods and RP-HPLC method for the simultaneous estimation of Aripiprazole and Clozapine in Synthetic Mixture. UV Spectrophotometric methods applied are: 1) First Derivative Zero Crossing Point Method 2) Absorption factor method 3) Chemometrics assisted UV spectrophotometric methods. The RP-HPLC method applied by QbD approach. Proposed techniques have been validated as per ICH guideline and successfully applied to the simultaneous estimation of Aripiprazole and Clozapine in their Synthetic Mixture. The results of analysis have been validated statistically and by recovery studies.

Keywords: Aripiprazole (Ari), Clozapine (Clz), classical and novel UV spectrophotometric methods, RP-HPLC methods by QbD approach.