Development and Validation of U.V Method for ...

Development and Validation of U.V Method for The Estimation of Dasatinib In The Tablet Formulation

Author Name : M. Ramakrishna, I. Sivasai, P. Gopi, SK. Ameena, K. Jayendra, SK. Mymoon, J. N. Suresh Kumar

ABSTRACT

A cost effective, precise, accurate, simple stability indicating UV-Spectrophotometric method was developed for the determination of Dasatinib in bulk and tablet dosage form. Dasatinib shows highest λmax at 323 nm. Beer's law was found over a concentration range of 2-10 μg/ml with superior correlation coefficient (r ²= 0.999). The Detection limit (DL) & Quantitation limit (QL) were found to be 0.3968 μg/ml and 1.2025 μg/ml respectively. The results of the Dasatinib recovery analysis were found to be 99.9505 ± 0.0002 to 100.0645 ± 0.0002. Percentage assay of Dasatinib tablets (Dasanat) got more than 99.88 %.  Dasatinib was subjected to alkali, acid, oxidation, thermal, UV light degradation. Dasatinib is more unstable in acidic, oxidation, thermal and stable in alkaline and ultra violet (UV) light irradiation. The Proposed spectrophotometric method was validated as per the ICH Q1A (R2) guidelines. While estimating the Dasatinib in tablet formulation there was no interference of additives & excipients. Hence this method can safely be employed for the routine quality control analysis of Dasatinib in bulk and tablet dosage form.

Keywords:   validation parameters, U.V, EC