Abstract

ULTRAFAST LIQUID CHROMATOGRAPHIC ESTIMATION OF A NOVEL ANTI-HEPATITIS C AGENT PRESENT IN PHARMACEUTICAL DOSAGE FORM

*Sagar Suman Panda, Apurba Debasriya, Bera Venkata Varaha Ravi Kumar and
Abha Kumari

Abstract

An ultrafast liquid chromatographic method was developed and validated for estimation of a novel anti-hepatitis C agent, boceprevir (BOC) in bulk and tablet formulation. Chromatography was performed on a C-18 column using methanol: 10mM TBAHS (80:20, v/v) as mobile phase flowing at 1.2ml/min. PDA detection was carried out at 203 nm. Retention time for BOC was 2.451min.The method linearity was observed over a range of 2.5-40μg/ml. The developed method was validated as per ICH guidance for various validation parameters such as accuracy, precision, sensitivity, selectivity and specificity etc. The developed method was found suitable for estimating analyte in both bulk as well as in tablet dosage form. Overall the method was rapid, reliable and possesses the potential of application in routine and bioanalytical purposes.

Keywords: Boceprevir, UFLC, validation, robustness.