Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2014, 6 (6):117-121 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4 117 Scholar Research Library Development and validation of second order derivative methods for quantitative estimation of clopidogrel in bulk and pharmaceutical dosage form Rajan V. Rele Central Research Laboratory, D. G. Ruparel College, Matunga, Mumbai _____________________________________________________________________________________________ ABSTRACT Simple and precise UV spectrophotometric method by second order derivative was developed and validated for the estimation of clopidogrel bisulphate from bulk and its tablet formulation. The standard and sample solutions of clopidogrel bisulphate were prepared in 0.1 N hydrochloride acid. Clopidogrel bisulphate was estimated at 207.5 nm for the second order derivative UV-spectrophotometric method. Beer’s law was obeyed in the concentration range of 10 to 35 µg / ml with coefficient of correlation value 0.9991. The method was tested and validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation was of 1.2081% for the above method respectively. The proposed method was successfully applied for the determination of clopidogrel bisulphate in pharmaceutical formulation. Results of the analysis were validated statistically and were found to be satisfactory. The proposed method is simple, easy to apply, low-cost and require relatively inexpensive instruments. Keywords: Clopidogrel bisulphate, UV spectroscopy, second derivative spectroscopy. _____________________________________________________________________________________________ INTRODUCTION Clopidogrel bisulfate, chemically (+)-(S) -(2-chlorophenyl)- 6,7-dihydrothieno [3,2-c] pyridine- 5(4H)-acetic acid methyl ester sulphate is a potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease and cerebro vascular disease. The mechanism of action of clopidogrel is irreversible blockade of the adenosine di-phosphate (ADP) receptor P2Y12 and is important in platelet aggregation, the cross-linking of platelets by fibrin. The blockade of this receptor inhibits platelet aggregation by blocking activation of the glycoprotein IIb/IIIa pathway. It Literature survey reveals the estimation of Clopidogrel bisulfate in pharmaceutical formulations by various HPLC[1-5],spectrophotometric[ 6-10], TLC[11] methods for assay of clopidogrel bisulphate. In the proposed work simple, rapid and reliable UV spectrophotometric method is developed for the determination of clopidogrel bisulphate. The method can be used for the routine analysis. In the proposed method optimization and validation of this method are reported.