Abstract

A VALIDATED HPTLC METHOD FOR THE DETERMINATION OF CLOPIDOGREL IN PHARMACEUTICAL DOSAGE FORMS

Jose Kurien*, P. Jayasekhar and Jinu John

ABSTRACT

A simple, selective and precise high performance thin layer chromatographic method was developed and validated for the determination of Clopidogrel in bulk drug and in formulation. The method uses aluminium plates pre-coated with silica gel 60F-254 as the stationary phase and hexane: methanol: chloroform: ammonia (16:2:1.5:0.5, v/v/v/v) as solvent system. This system gave compact spot for Clopidogrel (Rf: 0.65 ± 0.02). Densitometric analysis of Clopidogrel was performed in the absorbance mode at 254nm.The linear regression analysis data for the calibration plot showed good linear relationship over a concentration range of 1 – 10 μg spot-1. The values of correlation coefficient, slope and intercept were 0.998, 661.6 and -4.333 respectively. The method was validated for precision, robustness and recovery. The limit of detection and limit of quantification were 0.0786 and 0.785 μg spot-1, respectively.

Keywords: HPTLC; Clopidogrel; dosage forms; validation.