Development and Validation of UV Spectrophotometric Method for Quantitative Estimation of Prasugrel Hydrochloride in Bulk and Tablet Dosage Forms

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B. Famida*, S. Muneer, S. Parveen, S. Praveena, P. Sathya Sowmya, B. Mohammed Ishaq, Hindustan Abdul Ahad
Department of Pharmaceutical Analysis, Balaji College of Pharmacy, Anantapur –515001, AP. India.

Abstract
Prasugrel Hydrochloride is a novel platelet inhibitor used for acute coronary syndromes planned for percutaneous coronary intervention. The present research work discusses the development and validation of a simple and cost effective UV spectrophotometric method for the quantitative estimation of Prasugrel in bulk and its tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ_max) was found to be 222 nm in 0.1N HCl as a solvent. The percentage recovery of prasugrel was found to be in range 99-100 %. Beers law was obeyed in the concentration range of 5-50 μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.018x + 0.0949 and R² = 0.9973 was obtained. Validation was performed as ICH guidelines for Linearity, accuracy, precision, LOD and LOQ. The proposed method may be suitable for the analysis of ritonavir in bulk and tablet formulation for routine quality control purposes.
Keywords: Prasugrel, UV spectrophotometer, platelet inhibitor, ICH guidelines.