Stability-indicating method development and validation for estimation of clopidogrel bisulfate in pharmaceutical dosage form by reverse-phase high-performance liquid chromatography
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The present work was focused on the development and validation of reversed-phase high-performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, economical, and stability-indicating for the quantification of clopidogrel bisulfate in bulk and tablet formulation. The separation was attained on reversed-phase Princeton (C18) column with dimensions (250×4.6mm, 5μ) employing buffer which is a mixture of water (pH 3.0, adjusted with orthophosphoric acid) and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0ml/min. and detection was carried out at wavelength 240nm. The retention time under the optimized condition of clopidogrel bisulfate was found to be 4.388 minutes respectively. The linearity of the method was demonstrated in the concentration range of 45-120μg/ml for clopidogrel bisulfate with a correlation coefficient (r2) of 0.9996 respectively. The percentage relative standard deviation was <2% and percentage recovery was found to be 99.72-101.09% for clopidogrel bisulfate respectively. Assay of marketed tablet formulations was found to be 99.92% respectively. The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise, and economical, and could be used for regular quality control of clopidogrel bisulfate in bulk and tablet formulations.
Clopidogrel bisulfate, RP-HPLC, Validation, ICH guidelines.