Bioanalytical HPLC method development for simultaneous determination of valsartan and co-administered clopidogrel bisulfate and fenofibrate in stroke prevention in raw materials, spiked human plasma and tablets

Abstract

This study reports about simple, robust and reproducible method for simultaneous bioanalytical determination of Valsartan (VAL) and co-administered Clopidogrel bisulfate (CGB) and Fenofibrate (FEN) in raw materials, spiked human plasma and tablets using isocratic RP-HPLC method. The chromatographic separation is carried out using isocratic binary mobile phase consisting of 80 mM phosphate buffer pH 3: Acetonitrile (30: 70 %; v/v) at the flow rate of 1.1 mL/min and 33 °C. A Diode array detector at wavelength 214 nm was used. Retention times for VAL, CGB and FEN were 3.1, 5.1 and 6.4 min, respectively. The calibration curves obtained were linear over the concentration ranges of 2.5 - 100 μg/mL for both VAL and CGB and 5 -100 μg/mL for FEN. The mean extraction recoveries of VAL, CGB and FEN from spiked plasma were 75.38±1.34 %, 89.91±2.17 % and 96.92±6.02 %, respectively. The limits of detection and quantification were 0.86, 0.67, 1.11 μg/mL and 2.60, 2.03, 3.36 μg/mL for VAL, CGB and FEN, respectively. The method was applied to the analysis of these drugs in spiked human plasma and in tablets as they are commonly used as a combination for prevention of stroke. Results obtained show good accuracy, precision and acceptable recoveries from plasma samples.