Abstract

A STABILITY INDICATING METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE ESTIMATION OF SUNITINIB MALATE IN PHARMACEUTICAL FORMULATION BY RP-UPLC

Anuradha Masipogu*, Dodle Jayaprakash and Ravindernath Anisetti

ABSTRACT

A Rapid Specific, Precise, Reliable and Stability indicating UPLC method has been developed for the estimation of Sunitinib malate in capsule dosage form. This UPLC method was developed and validated in reverse phase column of Waters Acquity C8 (100mmx2.1mm ID) 1.7μm particle size in isocratic mode, and the sample was analyzed using 0.1%v/v Trifluroacetic acid and Acetonitrile in ratio of (55:45%v/v) as mobile phase at a flow rate of 0.6 ml/min and detection was carried out at 268 nm with short retention time at 3min. Sunitinib malate capsule formulation samples were well extracted with mobile phase as a diluent and method precision results were obtained in between 95.0 to 105.0%. This capsule formulation assay method was validated as per the ICH Validation guidelines. Method has shown Precise, Specific, Linear, sensitive, Accurate, Robust and Rugged results. For Linearity Parameter, Calibration curve was plotted in the concentration range of 25μg/ml to 75μg/ml for Sunitinib malate (50% to 150%) and shown correlation coefficient of >0.999, and recoveries from capsule dosage form were obtained between 98.0 and 102.0 % at level of 50% to 150%. Method has shown peak purity results within the acceptance criteria hence method has stability indicating property. This method can be easily adopted by Quality control to analyse the development samples as well as stability samples.

Keywords: UPLC, Sunitinib malate, Waters Acquity C8, Method validation, Forced degradation studies.