Method Development, Validation and Degradation Studies of Imatinib Mesylate by UPLC
Punna Venkateshwarlu
Department of Pharmaceutical Analysis & Quality Assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa-388421, Anand (Dt), Gujarat, India.
Mehul M. Patel *
Department of Pharmaceutical Chemistry, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa-388421, Anand (Dt), Gujarat, India.
*Author to whom correspondence should be addressed.
Abstract
Background: A simple, reliable and economical method was used for the study of imatinib mesylate. The optimized chromatographic conditions were determined by using a C18 intersil ODS (250 X 4.6 mm X 5µm) and a mobile phase containing phosphate buffer (pH 3.0): Acetonitrile: Methanol (40:30:30) v/v was pumped at 1 ml/min flow rate. The injected sample volume is 20 μL and the analytes were eluted at 254 nm.
Results: The Retention time of imatinib mesylate was 3.503 minutes. The system suitability percentage RSD of imatinib mesylate is 0.27. The Assay of imatinib mesylate was found to be 99.37%.The imatinib mesylate LOD, LOQ values of were found to be 0.901 and 2.73μg/ml. Regression equation was found to be y= 96.59x + 10.76 form linearity calibration graph. Imatinib mesylate was degraded in acid and peroxide stress conditions, and no degradation was obtained in base, photolytic and thermal conditions.
Conclusion: The reliable UPLC method validation data observed that which can be used for analyzing routine quality control. The method is economical due to the run time is reduced, which can be used in regular quality control tests in the industry.
Keywords: Imatinib mesylate, retention time, validation, degradation studies, % RSD