UV-SPECTROPHOTOMETRIC AND RP-HPLC METHODS FOR THE ESTIMATION OF PRASUGREL HYDROCHLORIDE IN BULK AND TABLET FORMULATION

摘要

Objective: Prasugrel hydrochloride is used as an anti-platelet drug for the treatment of myocardial infarction prevention, Thrombosis prevention after percutaneous coronary intervention, Platelet-aggregation inhibitors etc. The aim of the present study is to develop a new analytical method for the estimation of Prasugrel hydrochloride in bulk and in tablet dosage form. Methods: Spectroscopic method-1 and RP-HPLC method-2 have been developed for the quantification of Prasugrel hydrochloride in bulk and in the formulation. These methods are simple, cost effective, accurate and precise. Results: In method-1, Prasugrel hydrochloride showed maximum absorbance at 252 nm in methanol which is selected as solvent for analysis based on it stability. Beer's law obeyed in the concentration range of 10-60 mcg/ml. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 1.0195 and 3.0896 mcg/ml respectively. In RP-HPLC (method-2), the mobile phase selected is Acetonitrile: Trifluroacetic acid in the ratio 45:55% v/v. The flow rate was 0.1 ml/min. The linearity range was found to be 10-60 mcg/ml. The formulation EFIPLT was selected for analysis and the amount present was found to be 100.53% and 106.95% for method 1 and 2 respectively. Conclusion: Both the methods are validated as per ICH guidelines. The methods were found to be simple, accurate, precise and rapid