HPLC Method for Determination of Aspirin, Rosuvastatin, Ezetimibe and Clopidogrel in Combination Drug Products

Abstract

A single HPLC method for the determination of four active ingredients viz. aspirin, rosuvastatin, ezetimibe and clopidogrel in less run time is developed. HPLC method was developed and validated. X-terra C18 100 × 4.6 mm, 3.5 μ HPLC column, KH2PO4 buffer (mobile phase A) and acetonitrile (mobile phase B) were used. 20 μ injection volume, 1.0 mL/min flow rate, 230 nm and ambient column oven temperature were applied for separation. Gradient program: at 0 min mobile phase-B 13 %, at 4 min 13 %, at 8 min 44 %, 14 min 57 %, 17 min 57 %, 20 min 13 % and 25 min 13 %. Method validation was performed as per ICH guidance with precision, linearity, specificity, accuracy, ruggedness and robustness. Validation results were satisfactory and this method can be applied for regular drug product manufacturing