METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR ASSAY OF TRAMETINIB IN PHARMACEUTICAL DOSAGE FORM

B. Ramakrishna, N. Sarat Babu and NVS Naidu*

ABSTRACT

A simple, selective, precise and accurate High Performance Liquid Chromatographic method for the analysis of Trametinib was developed in Pharmaceutical Dosage form. Trametinib showed maximum absorption at 245nm. This method achieved by using isocratic elution with ratio ammonium acetate buffer: methanol: acetonitrile: tetrahyrofuron mobile phase at 40:30:20:10V/V. The developed HPLC method was validated for Linearity, Accuracy, Interday Precision, Specificity & Selectivity, Robustness, Solution stability, limit of detection & limit of quantification. Stability Indicating Methods were developed for Trametinib in Pharmaceutical Dosage form under hydrolytic stress condition (5N HCl, 5N NaOH); Oxidation condition (5% H2O2) and dry heat condition, Thermal condition, UV light. From this study, it was found that drug is not susceptible for degradation to hydrolytic condition, oxidation condition, dry heat, UV light, and thermal condition. All the developed methods were successfully applied to determine the drug in Pharmaceutical preparation.

Keywords: HPLC, Trametinib, Spectrophotometric method, Pharmaceutical Dosage.