STABILITY INDICATING UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CRIZOTINIB IN PHARMACEUTICAL DOSAGE FORMSAbstract
A stability indicating method was developed for the estimation of Crizotinib in pharmaceutical dosage form by using Ultra Performance Liquid Chromatography (UPLC). The separation was done on isocratic mode with Hibra C18 (100 mm × 2.1 mm, 2 µ) column and 0.1% Ortho-phosphoric acid and acetonitrile (45:55% v/v) as mobile phase at a flow rate of 0.3 mL/min and at room temperature. The detection was done at a wavelength of 327 nm. A good linearity was observed in the concentration range of 37.5 µg/mL – 225 µg/mL, with a correlation coefficient of 0.999. The method was validated according to the ICH guidelines. The developed method was found to be accurate and precise, with % recovery 99.9% – 100.18% and % relative standard deviation 1.1. The drug was found to be stable at forced degradation conditions and the net degradation was found to be within the limits. The developed method can be used for the quality control of Crizotinib in pharmaceutical dosage form.
J. Bandla* and S. Ganapaty
Department of Pharmaceutical Analysis and Quality Assurance, Faculty of Pharmacy, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Medak, Telangana, India.
07 July, 2017
11 September, 2017
14 September, 2017
01 April, 2018