Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF PRASUGREL AND ASPIRIN

B.A.Patel*, S. Alvi* and S.J. Parmar*

ABSTRACT

A simple & precise Stability indicating HPTLC method has been developed & validated for the simultaneous estimation of Prasugrel (PRA) & Aspirin (ASP) from Dosage form. The method employed TLC aluminum plates precoated with silica gel 60 GF 254 as the stationary phase. The solvent system comprised Carbon Tetrachloride: Ethyl Acetate: Acetic Acid (7.5:2.4:0.1, v/v/v). This system was found to give good result for both the drugs (Rf value: of ASP 0.34cm & PRA 0.58cm).Spectrodensitometric scanning-integration was performed at a wavelength of 240nm.The calibration curve was found to be linear within the concentration range of 150ng/spot to 900ng/spot for PRA and1125-6750 ng/spot for ASP. The regression data for calibration curve shows good linear relationship with r2 = 0. 9981 & 0.9979 for PRA & ASP respectively. The method was validated as per ICH guidelines. Thus, the proposed method can be used successfully for routine analysis of PRA & ASP from dosage form.

Keywords: Validation, Stability indicating HPTLC method, Prasugrel & Aspirin.


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