Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN AND CLOPIDOGREL BISULPHATE IN DOSAGE FORM

M. D. Mitkal*, R. N. Jalkote and S. H. Rajeghadage

ABSTRACT

A simple, reproducible and efficient reverse phase High performance liquid chromatography (RP-HPLC) method has been developed for estimation of Rosuvastatin and Clopidogrel in its tablet dosage forms by using RP-HPLC C18, 2504.6mm, particle size 5m column. Methanol Water (80:20 v/v), as mobile phase, at flow rate 1 mL/min. From the overlay spectrum 231 nm was selected as a wavelength of measurement. The retention times were 3.45 and 4.98 min. for Rosuvastatin and clopidogrel bisulphate, respectively. Calibration plots were linear (r2 >0.998) over the concentration range 1-5μg/ml for Rosuvastatin and 7.5-37.5 μg/ml for clopidogrel bisulphate. The method was demonstrated to be precise, accurate, specific and robust. The proposed method was successfully used for quantitative analysis of capsules. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible.

Keywords: Rosuvastatin, Clopidogrel bisulphate, simultaneous Estimation, development and validation, RP- HPLC.