Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF VENLAFAXINE HYDROCHLORIDE IN BULK AND DOSAGE FORM

Tejeswini Patil*, Jyoti Sonawane, Sonali Rathod and Krishna Sanap

Abstract

The presented experiment was intended to develop a sensitive, precise, economic and accurate RP-HPLC method for the analysis of Venlafaxine (VNF) in bulk and pharmaceutical dosage forms. Mobile phase composition of Acetonitrile: Water dissimilar amalgamations were studied as mobile phase on a C18 stationary phase. A mobile phase composition in the ratio of 55:45 at pH 4.3 adjusted with ortho phosphoric acid was found to be the most appropriate of all amalgamations studied. Seeing as, the chromatographic peaks were better definite and determined and approximately complimentary from tailing. The retention time estimated for VNF was 4.61min (Mean RT of SST). System suitability testing was carried out by means of six repeated injections of standard solution of the VNF (10μg/ml) and the calculated parameters were obtained within the acceptance criteria as per ICH Q2R1 guideline. The peak areas of Venlafaxine were reproducible as indicated by % RSD within acceptance criteria. A good linear relationship (r2 = 0.9987) was observed between the standard concentration of VNF and the respective mean peak areas in the range of 5-30μg/ml. The regression curve was constructed by linear regression fitting and its regression equation was y = 15121x – 1994.3. Where, Y gives mean peak area and X is the concentration of the drug). Validation of the developed RP-HPLC method of VNF was performed by ICH guideline Q2R1.

Keywords: RP-HPLC, Venlafaxine, Validation, ICH guidelines.