Mon, 22 Jan 2018

Development, Validation and Stability indicating RP-HPLC Method for the Analysis of Trifluoperazine Hydrochloride in API and Pharmaceutical Dosage form

L Kalyani1 and Chava Venkata N Rao2 *

1. Department of Chemistry, NRI Institute of Technology, Perecherla, Guntur Dt., A.P.

2. Department of Chemistry, NRI Institute of Technology, Pothavarappadu, Agiripalli Mandal, Krishna Dt., A.P., India, 521 212.  Mobile: +91 98486 22100


ABSTRACT

A simple, cheap, fast and accurate Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for determination of Trifluoperazine Hydrochloride and its degraded products in pharmaceutical dosage form. This method was developed by using an analytical Zodiac C18 Column (250 mmx4.6mm, 5µm) and mobile phase comprises of 70% methanol and 30% acetonitrile. The method was validated and found to be linear, selective, accurate, robust, rugged and precise. The lower Limit of Detection (LOD) and lower Limit of Quantification (LOQ) respectively were 1.50 µg/ml and 5.0 µg/ml.  The methods utilized in this study are the degradation of drug i.e. aqueous, 0.1N HCl, 0.1N NaOH, 3% H2O2, thermal, photolytic and UV light. Developed HPLC method is able to separate all degrading products from any stress condition from drug peak by resolution of more than 2. This developed method can be used for routine analysis for the estimation of Trifluoperazine Hydrochloride in bulk and in tablet dosage form in pharmaceutical industry because it is simple, cheap and accurate.

Keywords: RP-HPLC, Trifluoperazine Hydrochloride, Validation


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