Method Development and Validation for Simultaneous Estimation of Dasatinib and Erlotinib by Using RP HPLC in Pharmaceutical Dosage Form

The present study describes a newly developed, optimized and validated isocratic RP HPLC method for the separation of two tyrosine kinase inhibitors Dasatinib DST and Erlotinib ERT with Methyl paraben MPB as internal standard IS , in bulk and pharmaceutical formulations with the aid of Chemometrics, multi criteria decision making MCDM approach. The separation was achieved by using Phenomenex Enable C18 column 15×4.6 mm id, 5µm particle size and PDA UV detection at 277nm.The range of independent variables used for the optimization were MeOH 60 70 , pH 2 2.5 and flow rate 0.3 0.8ml min. The influence of these independent variables on the output responses capacity factor of the first peak k1 , resolution Rs and separation a of the second peak and retention time tR3 were evaluated. Using this strategy, mathematical model was defined, and response surface were derived for the separation. The coefficients of determination R2 were more than 0.9258 for all the models. The four responses were simultaneously optimized by using Derringers desirability functions and MCDM approach. Optimum conditions chosen for assay were MeOH, 0.01mM KH2PO4 pH 2.5±0.5 adjusted with diluted orthophosphoric acid solution 68.03 31.97v v and flow rate of 0.8 mL min. Peak area ratio of the analyte and internal standard was used for the quantification of pharmaceutical formulation samples. Total chromatographic analysis time per sample was approximately 9.0 min with DST, MPB IS and ERT eluting with retention times of 2.7, 3.2, and 6.0 minutes respectively. The optimized assay condition was validated as per ICH guidelines and applied for the quantitative analysis Sprycel DST tablet and Tarceva ERT capsule. Dara. Varun | Kumaraswamy. Gandla | R. Lalitha | M. Muralikrishna "Method Development and Validation for Simultaneous Estimation of Dasatinib and Erlotinib by Using RP-HPLC in Pharmaceutical Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3 , April 2021, URL: https://www.ijtsrd.com/papers/ijtsrd41117.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/41117/method-development-and-validation-for-simultaneous-estimation-of-dasatinib-and-erlotinib-by-using-rphplc-in-pharmaceutical-dosage-form/dara-varun