DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION OF IMATINIB MESYLATE IN API AND TABLET DOSAGE FORM

Abstract

A simple, rapid, selective and quantitative HPTLC method has been developed and validated for determination of Imatinib Mesylate in bulk and tablet dosage form. The Imatinib Mesylate samples were applied on TLC Aluminium plate pre coated with Silica gel60 GF254 and developed using Methanol: Choloroform (8: 2) v/v as a mobile phase. The bands were scanned at λ=279 nm using Camag TLC scanner 3 and detection and quantification were carried out densitometrically using an UV detector. The Rf value was found to be 0.22. The linearity of the method was found to be within the concentration range of 50-300 ng/spot and its percentage recovery was found to 96.55 %. The limit of detection and the limit of quantification were found to be 16.36 ng/spot and 49.59 ng/spot respectively. The Coefficient of determination (r2) was 0.9996. The regression equation was found to be y = 17.209x + 63.798. The method was also validated for precision, specificity and recovery. This developed method was used to analyse marketed formulation.