A simple, rapid, cost-effective, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of prasugrel and aspirin in bulk and tablet dosage form. It was found that the excipient in the tablet dosage form does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on phenomenex C8 column( 250×4.6 mm, 5µ) with a mobile phase composed methanol: water 80:20 v/v in isocratic mode of separation at flow rate 1ml/min. The detection was monitored at 236nm. The calibration curve for aspirin and prasugrel was found to be linear from 2 to 18 µg/ml and 15 to 135 µg/ml respectively. The interday and intraday precision was found to be within limits. The proposed method validated according to the ICH guidelines and has adequate sensitivity, reproducibility and specificity for the determination of prasugrel and aspirin in bulk and its tablet dosage forms. LOD and LOQ for prasugrel were found to be 30 ng/ml and 100 ng/ml respectively. LOD and LOQ for aspirin were found to be 10 g/ml and 30 ng/ml respectively. Accuracy for prasugrel were found to be 98.13-101.98 and for aspirin 99.92-100.26 respectively. The Robustness study and percentage of assay of the formulation were found within limit as per ICH guidelines.
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