Original Articles: 2015 Vol: 7 Issue: 12
Development and validation of rapid RP HPLC-PDA method for the analysis of Pazopanib hydrochloride in bulk, dosage forms and in in vitro dissolution samples
Abstract
The prime objective of the current work is to develop a simple, rapid, efficient, economical and LC-MS compatible RP HPLC-PDA method for the analysis of Pazopanib hydrochloride in bulk, dosage forms and in dissolution samples. Samples were chromatographed on Agilent Zorbax Eclipse plus C18 column (150 x 4.6mm, 5μm) with a mobile phase composed of 10mM Ammonium acetate: methanol (40:60 v/v) in isocratic mode at a detection wavelength was fixed at 268nm. The retention time of PAZ was 2.2 minutes and the method showed a good linearity in the concentration range of 20μg/mL to 300μg/mL with linear regression equation y = 9987x + 19893 and correlation coefficient 0.999. The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.396 and 1.200 μg/mL respectively. The method was validated for accuracy, specificity, linearity, limit of detection, limit of quantification, precision, robustness and stability. All the validation parameters were within the compendial requirements. The proposed method was successfully adopted for the analysis of Pazopanib Hydrochloride (PAZ) in bulk, pharmaceutical dosage forms and in dissolution samples.