Determination of Clopidogrel in Pharmaceutical Preparation by UV Spectrophotometry and High Performance Liquid Chromatography Methods

Abstract

UV-Visible spectroscopy and HPLC methods were developed and validated for determination of clopidogrel in bulk and pharmaceutical formulation. In spectroscopy, clopidogrel spectrum at different solutions were taken and the best absorbance value was obtained at 202 nm wavelength in methanol-acetonitrile (50:50,h/h) solution. In HPLC, parameters were optimized as follows: mobile phase was acetonitrile-methanol-water (45:45:10, v/v/v), C₁₈ reserve phase column were preferred, 0.9 ml/min mobile phase of flow rate and  10 µl injection volume were selected and all measurements were performed at 230 nm wavelength. Meloxicam were used as internal standard in HPLC. Linearity, analytic recovery, intra and inter-days precision and accuracy were investigated in order to perform validation process, It was stated that HPLC measurements were linear at 0.25-30 µg/ml concentration and UV at 1.1.25-25. Intra and Inter-days precision and accuracy values were %5.38 and %2.66(for HPLC method); %3.77 and %3.60 (for UV method); analytic recovery value was average of %99.5 for both methods. Developed and validated HPLC and UV-Vis methods were applied to pharmaceutical preparations including active substance, clopidogrel.