METHOD DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF ASSAY OF ANTI CANCER DRUGS- AXITINIB, BOSUTINIB, ERLOTINIB HYDROCHLORIDE, GEFITINIB AND PEMETREXED DISODIUM DRUGS IN API FORM.

V. Ashok Chakravarthy* and B. B. V. Sailaja

ABSTRACT

The objective of the present work is to develop a simple, efficient and reproducible spectrophotometric method for the quantitative estimation of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium drugs in its active pharmaceutical ingredient (API) form. The developed UV-Visible spectrophotometric method for the quantitative estimation of drugs – Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium is based on measurement of absorption at a wavelength maximum (λmax) of 336nm, 269nm, 247nm, 250nm and 225nm using dimethylsulphoxide (DMSO) and methanol as diluents. The method was validated in terms of specificity, precision, linearity, accuracy, and robustness as per the ICH guidelines. The method was found to be linear in the range of 32% to 200% for Bosutinib and Erlotinib hydrochloride drug substances; 40% to 140% for Pemetrexed Disodium drug substance; 50% to 150% for Axitinib and Gefitinib drug substances. The percentage recovery values were in the range of 98.4 to 100.4% for Axitinib, 98.5 to 100.1% for Bosutinib, 99.7 to 100.4% for Erlotinib hydrochloride, 99.7 to 100.5% for Gefitinib and in the range of 99.8 to 100.5% for Pemetrexed Disodium at different concentration levels. Relative standard deviation for precision and intermediate precision results were found to be less than 2%. The correlation co-efficient value observed for linearity of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium drug substances was not less than 0.99 for their respective drugs. Results obtained from the validation experiments prove that the developed method is quantified for the estimation of assay of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium drug substances. The developed method can be successfully applied for routine analysis, quality control analysis and also suitable for stability analysis of assay of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium in API form as per the regulatory requirements.

Keywords: Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib, Pemetrexed Disodium, Method Development, Validation, UV-Visible spectrophotometry.