Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF DASATINIB BY REVERSE PHASE- ULTRA -HIGH PERFORMANCE LIQUID CHROMATOGRAPY (RP-UHPLC) IN ORAL SOLID DOSAGE FORMS

*Divyapriya R., Suresh Kumar S., Kanmani R., Gokulan P. D., Senthil Kumar K. L.

ABSTRACT

Analytical technique includes volumetric, electrochemical, spectroscopic, chromatographic analysis. The current work aimed to develop and validate Dasatinib measurement procedure using RP-UHPLC (Reverse phase- Ultrahigh performance liquid chromatographic method) for oral solid dosage forms. It is a rapid, sensitivity, efficacy, resolution, with faster output and less solvents required at a reduced cost. UHPLC, like HPLC, is a method for identifying, quantifying and separating mixture components. Using high pressure to force solvents through the column. UHPLC uses particles smaller than 2µm is used. It offers better separation than HPLC. Chromatographic conditions were achieved via column water C18;3.0mm×50mm;2.1 microns, resulting in a wavelength of approximately 300nm. The Mobile phase consists of Acetonitrile based buffer mixture (400:600) at a flow rate of 0.3ml/min. Due to the injection volume is about 10µl. Dasatinib retention time was reported to be 2.050min. %RSD of the Dasatinib is 0.14%. Dasatinib was assayed at 100.88%. The Regression equation for Dasatinib is Y= Y=0.8765×0.4643&r2=0.9999. Retention time decreased as did run time. This created approach was validated using several parameters stated in the ICH guidelines, Q2.

Keywords: Dasatinib, Anticancer drug, UHPLC, Acetonitrile, 300nm, Method development and validation.