ISSN : 2663-2187

ANALYTICAL HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF PRASUGREL TABLETS

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Prasanthi Samathoti ,Gurnani Haritha , Mangirish Deshpande, Pranjali Bajrang Chole , Tarun Parashar , Sarita Garg , Ramenani Hari Babu ,Vema Kiran , Trinayan Deka
» doi: 10.33472/AFJBS.6.9.2024.1240-1250

Abstract

Prasugrel hydrochloride functions as an agent that inhibits platelet activity and prevents the formation of blood clots. The mortality rate attributed to thrombosis has been increasing, therefore highlighting the need to develop methodologies for the evaluation of pharmaceutical interventions. The objective of this study was to develop a Prasugrel Hydrochloride 5mg tablet with high reliability, accuracy, and precision using RP-HPLC methodology. In order to quantify the amount of Prasugrel Hydrochloride present in tablets, a reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated. A C18 SunfireTM (5 µm, 250 mm × 4.6 mm) analytical column was used in an isocratic mode. The mobile phase consisted of a mixture of methanol and water in a ratio of 80:20 (v/v) and KH2PO4with a pH of 6.5. The analyte was monitored at a wavelength of 245 nm with a flow rate of 1.0 ml/min. The technique was validated to assess the system's applicability, specificity, precision, accuracy, linearity, ruggedness, and robustness. Linearity was successfully attained within the range of 25 parts per million (ppm) to 125 ppm, as shown by a high correlation coefficient of 0.9999. The reliability and durability of the technique were shown by the consistent findings obtained despite variations in flow rate and temperature, as well as when the analysis was conducted by a different analyst, on a different system, and with a different column. Given that all the criteria for system suitability were within the permissible range, it was concluded that the system has the capability to conduct the test.

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