Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TRIFLUOPERAZINE DRUG IN PHARMACEUTICAL DOSAGE FORM

Sarala S. Solat, R. B. Laware* and S. S. Siddheshwar

ABSTRACT

A new stability indicating method was developed for the estimation of trifluoperazine in API, this method was also successfully utilized for the estimation of drug in tablet dosage forms. In Reverse Phase High Performance Liquid Chromatography Method the chromatographic system was equipped with Inertsil ODS C18 column (150mm x 4.6mm, 5μm), as stationary phase and PDA detector set at 250 nm, mobile phase was selected for is the mixture of buffer pH 3 and acetonitrile in the ratio 55:45 v/v respectively at a flow rate of 1.0 ml/min. Retention time for trifluoperazine was found to be 4.7 min. The % recoveries of trifluoperazine were found to be 97.0 - 103.0%. Method was statistically validated for accuracy, precision, specificity, and robustness according to ICH guidelines. Developed HPLC method is able to separate all degradants produce form any stress condition from drug peak by resolution of more than 2. Trifluoperazine was found stable in Acid, Base and Oxidative condition. The method was found to be simple, precise, specific and accurate. The newly developed method can be used for routine analysis for the estimation of Trifluoperazine in bulk and tablet dosage form in pharmaceutical industry.

Keywords: Trifluoperazine, RP-HPLC, Stability indicating, Method Validation.