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Development and validation of second order derivative methods for quantitative estimation of clopidogrel in bulk and pharmaceutical dosage form | Abstract
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Abstract

Development and validation of second order derivative methods for quantitative estimation of clopidogrel in bulk and pharmaceutical dosage form

Author(s): Rajan V. Rele

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.