Determination of trametinib in pharmaceutical formulations by rp-hplc method

Abstract

A new simple, accurate, economic, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Trametinib in bulk form and its pharmaceutical dosage form. Chromatographic separation was carried out on Zorbax C18 (4.6mm x 250mm, 5mm, Make: X terra) column using a mixture of Acetonitrile: Methanol: Water (50:30:20% v/v) as the mobile phase at a flow rate of 1.0 ml/min, the detection was carried out at 245nm. The retention time of the Trametinib was found to be 5.462 ±0.02min. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 50-90 mcg/mL for Trametinib.  The correlation coefficient was found to be 0.999. The LOD and LOQ for Trametinib were found to be 1.6µg/mL and 4.8µg/mL respectively. The proposed method was found to be good percentage recovery for Trametinib, which indicates that the proposed method is highly accurate. The proposed HPLC conditions ensure sufficient resolution and the precise quantification of the compounds. Results from statistical analysis of the experimental results were indicative of satisfactory precision and reproducibility. Hence the developed method was successfully applied to determine Trametinib in pharmaceutical formulations