SYSTEMATIC LC-MS/MS METHOD FOR QUANTIFICATION OF 2,3-DIMETHYL-2H-INDAZOLE-6-AMINE CONTENT IN PAZOPANIB HYDROCHLORIDE

摘要

A sensitive and rugged method was developed and validated by using liquid chromatography coupled with triple quadrupole spectrometer (LC/MS/MS) technique for the determination of 2,3-dimethyl-2H-indazole-6-amine content in pazopanib hydrochloride. The separation was achieved by using Hypersil BDS C18 15 cm *4.6 mm length and 5.0 μm width column. Mobile phase-A was 0.1% formic acid in water and mobile phase-B was acetonitrile in the ratio of 45:55 v/v with 1.0 mL/min flow rate in isocratic mode. The limit of detection (LOD) and limit of quantification (LOQ) signal to noise ratio values were obtained as 3.7 and 10.9 respectively. The linearity range between 0.6 to 6.0 ng/mL and the correlation coefficient was found 0.999. The recovery found between 98.8 to 101.3% at four different levels.