Validated RP-HPLC Method Development of Pazopanib in Bulk and its Pharmaceutical Dosage Form

摘要

Objectives: An accurate, sensitive, precise and rapid method for analysis and quantification of Pazopanib by Reverse Phase High Performance Chromatography (RP-HPLC) was developed and validated. Pazopanib in bulk and formulations were analyzed and quantification. Methods: Pazopanib in bulk and formulations were analyzed on Phenomenex enable Csub18/sub column (15x4.6mm, 5μm particle size) as stationary phase. Mobile phase was composed of acetonitrile and phosphate buffer (pH 5) in the ratio of 60:40%v/v at a flow rate of 1.2ml/min. elutes were analyzed using PDA detector at a detection wavelength of 290nm. The proposed method was validated by ICH guidelines, Validation of Analytical Procedures: Text and Methodology Qsub2/sub (R1). Results: In this study, the chromatographic peaks of Pazopanib showed good resolution with retention time of 2.190min. Pazopanib showed an excellent linearity with 0.998 of correlation coefficient. Other validation parameters including precision, specificity, accuracy and robustness demonstrated good reliability in the quantification of Pazopanib. Conclusion: Thus the newly developed and validated method can be conveniently used for the quantification of Pazopanib in bulk and formulation. The method can also be applied to multi-component drug analysis.