Abstract

METHOD DEVELOPMENT AND VALIDATION FOR RELATED SUBSTANCES OF BOSUTINIB MONOHYDRATE BY RP-HPLC METHOD

Yogendra B. Parmar*, Dharmesh Shah, Yashraj A. Majmudar, Ketul C. Kaka, Arpan S. Patel, Pankaj D. Kankad and Uday G. Sartanpara

ABSTRACT

An accurate, sensitive and rapid gradient reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for related substances of Bosutinib monohydrate. HPLC analysis was performed on Inertsil ODS 3V (250 x 4.6) mm, 5 m. Column temperature maintained at 40°C conditions. Chromatographic separation was achieved with mobile phase gradient program at flow rate of 0.7mL/min. the injection volume was 15μl. The UV detection wavelength was 250nm. The method suitability was checked and validated according to the ICH guidelines for specificity, linearity, accuracy, precision, limit of quantification, limit of detection. Limit of detection each impurity is less than 0.05% w/w indicating that the developed method is highly sensitive. The calibration curve was found to be linear within the concentration range of 0.5μg/mL to 10μg/mL. The regression data for calibration curve shows good linear relationship. Correl coefficient (r2) of each impurity is greater than 0.9991. The experiment results are given in detail in this research article.

Keywords: RP-HPLC, Method validation, Method Development, BST, Related substances.