Abstract

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN AND GLIBENCLAMIDE

Sheikh Hasibul Islam, Md. Alauddin, Farzana Alam, Md. Rafi Anwar, Irin Dewan, S.M. Ashraful Islam*

ABSTRACT

A convenient and rapid reverse phase-HPLC (RP-HPLC) method has been developed and validated for simultaneous estimation of rosuvastatin (RSV) and glibenclamide (GBC) according to international conference on harmonization (ICH) guideline. The separation of these two drugs was attained on C18 (ZORBAX Eclipse Plus 4.6 mm×150 mm, 5μm) with isocratic mobile phase containing methanol: acetonitrile: 0.02 M phosphate buffer pH 3.5 (60:20:20 v/v/v) and flow rate 1.0 ml/min with diode array detector at 237 nm. The rosuvastatin and glibenclamide were determined simultaneously with good linearity in a range of 5-22 μg/ml with R2 value 0.999 and 0.998 respectively. Stability-indicating stress conditions (temperature, acid and hydrogen peroxide) were applied to this method as per ICH guidelines. This method was applied to pharmaceutical formulation (99.29±1.03% for RSV and 99.30±0.13% for GBC) and was also subjected to analysis of rabbit plasma-spiked with rosuvastatin and glibenclamide (recovery 96.97±0.69% for RSV and 97.68±0.05% for GBC). So the proposed RP-HPLC method is effective and accurate for estimation of rosuvastatin and glibenclamide in combined dosage-form and in biological sample.

Keywords: RP-HPLC, rosuvastatin, glibenclamide, stability-indicating, rabbit plasma.