Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AVAPRITINIB BY RP-HPLC METHOD

Thakur Gajender Singh*, Jagadeesh Babu Vadlakonda and V. Rama Mohan Gupta

ABSTRACT

Analytical method was developed for the estimation of Avapritinib drug substance by liquid chromatography. The chromatographic separation was achieved on C18 column (Xterra R18 150*4.6, 5um) at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Formic acid in water: Acetonitrile (40:60). The flow rate was 1.0 ml/ min and UV detector at 296nm. The retention time for Avapritinib found to be 2.71 min. The proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 50-150μg/ml for Avapritinib.

Keywords: Avapritinib, Isocratic, HPLC, Formic acid, Xterra Rp18, Acetonitrile and Methanol, validation.