Abstract

MOST RELIABLE, SPECIFIC AND VALIDATED METHOD OF SUNITINIB MALATE FOR ITS RELATED COMPOUNDS INCLUDING PROCESS IMPURITIES

*Kishan Patel, Dharmesh Shah, Yashraj Majmudar, Vimal Patel, Anupama Modi, Chirag Surani and Mayank Patel

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 Sunitinib Malate. HPLC analysis was performed on YMC Pack ODS-A (250 mm x 4.6 temperature was maintained at 45°C conditions. Chromatographic separation was achieved with mobile phase gradient program at flow rate of 0.6ml/min. The injection volume was kept at 20μl. The UV detection wavelength was kept 268nm. 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 of each impurity was found to be less than 0.015% w/w indicating that the developed method is highly sensitive. The calibration curve was found to be linear within the concentration range of 0.075μg/ml to 1.125μg /ml. The regression data for calibration curve shows good linear relationship. Correlation coefficient of each impurity is greater than 0.9900. The experiment results are given in detail in this research article.

Keywords: RP-HPLC, Method Validation, Method Development, Sunitinib Malate, Related substances.