Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC AND UV-SPECTROSCOPY FOR SIMULTANEOUS ESTIMATION OF VARDENAFIL HYDROCHLORIDE AND SILDENAFIL CITRATE

Bhargav Patel, Anjani Chaudhari and Rajashree Mashru*

ABSTRACT

A simple, accurate, economical and reproducible RP- HPLC and UV spectroscopic methods for simultaneous estimation of two component drug mixture of vardenafil hydrochloride(VEL) and sildenafil citrate(SIL) in combination have been developed. Thedeveloped RP- HPLC and UVspectroscopic method including three methods(Derivative spectrophotometric method, Simultaneous equation method, Absorption factor method) for simultaneous estimation of using six mixed standards. Linearity was observed in concentration range of 1.0-6.0 μg/ml of VEL and 5.0-30.0μg/ml of SIL for RP-HPLC and 2.0-12.0μg/ml of VEL and 10.0-20.0μg/ml of SIL for UV spectroscopic method. Developed HPLC method is reverse phase chromatographic method using Bischoff-chrombudget C18 (250mm x4.6mm x5μm) columnand the mobile phase used THF: Methanol: Phosphate buffer pH-6.5 with 0.1%TEA (5:51:44). Results of analysis were validated statistically and by recovery studies.

Keywords: VEL and SIL, Spectrophotometry, RP-HPLC.