Analytical method development and validation for the estimation of Imatinib mesylate and its acid impurity in pharmaceutical formulation by RP-HPLC
Author(s):
Arun Kumar Kuna, Ganapaty Seru and GV Radha
Abstract:
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Imatinib mesylate and its Acid Impurity in pharmaceutical dosage form. The column used was HiQ Sil C18 (250 x 4.6 mm, 5μm), with mobile phase containing methanol and Acetate Buffer pH 3.5 in the ratio of 80: 20 v/v, the flow rate was 1.0 mL/ min and eluent was monitored at 273nm. The retention time for Imatinib mesylate was 8.083 and for Acid Impurity it is 6.208. The proposed method was validated and successfully applied to the estimation of Imatinib mesylate and Acid Impurity in formulations.
How to cite this article:
Arun Kumar Kuna, Ganapaty Seru, GV Radha. Analytical method development and validation for the estimation of Imatinib mesylate and its acid impurity in pharmaceutical formulation by RP-HPLC. Pharma Innovation 2018;7(12):418-422.