Validation of assay for bulk clopidogrel and for some tablet forms by reverse-phase high-performance liquid chromatography

AbstractA novel, simple, economical reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for quantifying clopidogrel in bulk and tablet form with greater precision and accuracy. Separation was achieved on a Develosil ODS HG-5 RP C18 (15cm×4.6mm, i.d. 5μm) column in isocratic mode with a mobile phase consisting of acetonitrile:phosphate (65:35) buffer (pH 2.85) with a flow rate of 1mL/min. Detection was carried out at 225nm. The retention time of clopidogrel was 7.48min. The method was validated as per the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Linearity was established for clopidogrel in the range 10–60μg/mL, with an r2 value of 0.999. The recovery of clopidogrel was 99.71–100.03%. The high recovery and low relative standard deviation confirm the suitability of the proposed method for estimating the concentrations of the drug in bulk and tablet dosage forms. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible for the determination of clopidogrel for quality control