METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IDELALISIB IN RABBIT PLASMA BY HPLCAbstract
A simple, rapid, sensitive, and accurate high performance liquid chromatography was developed for determination of Idelalisib (IL) in rabbit plasma using Ibrutinib as internal standard (IS). Idelalisib is a phosphoinositide 3-kinase inhibitor indicated in the treatment of chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). The analytes and IS were separated on a ODS (250 mm × 4.6 mm, 5 µm) column using Mobile phase composition as Buffer and Acetonitrile in the ratio of 85:15 v/v%. The total chromatographic runtime is 10.0 min with retention time for IL and IS at 7.195, and 5.435 min, respectively with a flow rate 1ml/min. The method is validated over a dynamic linear range of 0.02-4 µg/mL for IL with a correlation coefficient of r2 0.999. The method was validated as per the USFDA guidelines and the results were within the acceptance criteria for selectivity, sensitivity, linearity, precision, accuracy, recovery stability of solution and stability of solution in plasma.
A. Suneetha * and D. Sharmila
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur, Andhra Pradesh, India
20 June, 2016
15 August, 2016
27 August, 2016
01 December, 2016