A new analytical method development and validation of estimation of avapritinib by RP-HPLC
Abstract
Aim of present study is to develop simple, precise, and accurate method for quantitative estimation of Avapritinib in bulk form and marketed pharmaceutical tablet dosage form. The method was achieved on Symmetry C18 ODS (4.6mm×250mm) 5µm particle size column with mobile phase containing composition of Acetonitrile and Phosphate buffer (0.01M, pH-3.2) in the ratio of 30:70v/v at a flow rate 1.0ml/min with detection wavelength at 246nm. The linearity was obtained in the concentration range of 6-14 μg/ml for Avapritinib. The suitability of this method was proved by validation in accordance with ICH Q2 (R1) guidelines. The method was found to be accurate with percent recovery was found to be 100.130%. The %RSD for method repeatability and for intermediate precision were found be within the limits i.e. 0.441, 0.258 and 0.373 respectively. The proposed method was found to be simple and sensitive for routine quality control application of Avapritinib used in bulk form and pharmaceutical tablet dosage form.
How to Cite This Article
Dr. Ch. V Suresh, Salendra Greeshma, Santhosh Illendula, Dr. KNV Rao (2023). A new analytical method development and validation of estimation of avapritinib by RP-HPLC . International Journal of Multidisciplinary Research and Growth Evaluation (IJMRGE), 4(1), 175-182.