Stability-Indicating LC Method for the Determination of Prasugrel Hydrochloride in Pharmaceutical Dosage Form

• Published in: Scientia pharmaceutica Vol. 80; no. 2; pp. 379 - 391
• Main Authors: Ahirrao, Vinod K, Patil, Chabutai S, Bembalkar, Saroj B, Ubale, Sanjay B, Marathe, Rajendra P, Nawale, Rajesh B, Landge, Mahadev G, Pawar, Rajendra P
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 01.04.2012; Österreichische Apotheker-Verlagsgesellschaft
• Subjects: Pharmaceutical preparation; Prasugrel hydrochloride; Liquid chromatography; Method validation
• ISSN: 0036-8709; 2218-0532
• DOI: 10.3797/scipharm.1201-05

A simple, rapid and precise method was developed for the quantitative estimation of prasugrel hydrochloride in pharmaceutical dosage form. A chromatographic separation of prasugrel and its degradants was achieved with Zorbax XDB C(8), 150 × 4.6 mm, 3.5μm analytical column using aqueous solution of 0.05 M ammonium acetate pH 4.5 with acetic acid-acetonitrile (40:60 v/v). The instrumental settings include flow rate of 1.0 ml/min, column temperature at 30°C and detector wavelength of 254 nm using a photodiode array detector. Theoretical plates for prasugrel were 7023. Tailing factor for prasugrel was 1.11. Prasugrel was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Peak homogeneity data of prasugrel was obtained using photodiode array detector in the stressed sample chromatograms, which demonstrated the specificity of the method for the estimation in presence of degradants. The described method showed excellent linearity over a range of 10-300 μg/ml for prasugrel. The correlation coefficient is 0.999. The relative standard deviation of peak area for six measurements is always less than 2%. Overall, the proposed method was found to be suitable and accurate for quantitative determination and stability study of prasugrel in pharmaceutical dosage form.