Development and validation of RP-HPLC method for the determination of Pazopanib Hydrochloride (A tyrosine kinase inhibitor) in pharmaceutical dosage form Sankar P. Ravi*, Latha K. Saisneha, Sailu A. Bhavani, Taheera SK., Madhuri B. Department of Pharmaceutical Analysis, Vignan Pharmacy College, Vadlamudi, Guntur-522 213, Andhra Pradesh, India *Corresponding Author E-mail: banuman35@gmail.com
Online published on 30 April, 2021. Abstract A simple, precise, accurate, highly sensitive, rapid, and reproducible high-performance liquid chromatographic method was developed for the determination of Pazopanib Hydrochloride in bulk and tablet dosage form. Good quality chromatographic separation of Pazopanib Hydrochloride was carried out using Eclipse plus C18 column (4.5mm i.d. X 150mm, 3.5μm particle size) (based on 99.999% ultra-high purity silica) using mobile phase that containing 0.1% Orthophosphoric acid: Acetonitrile (55: 45% v\v) at a flow rate of 1.0mL/minute. The λmax of Pazopanib Hydrochloride in the mobile phase was found to be 271.4nm. It had a retention time of 1.430 min. The calibration curve was in the linear function of the drug in the concentration range of 2–10μg/mL (r2 = 0.999) for the HPLC method. The regression equation for Pazopanib Hydrochloride was found to be Y =70095 x + 28022 for HPLC. The Detection Limit (DL) and Quantitation Limit (QL) results of Pazopanib Hydrochloride were found to be 0.167548μg/mL 0.055290μg/mL for HPLC method, respectively. The developed methods are validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98–102% and minimum values of % RSD indicate the accuracy of the method. The % assay of the Pazopanib Hydrochloride was found to be 99.85±12, which was in good agreement with the labelled claim. The detailed quantitative results of the study show that this method is precise, accurate, cost-effective, and robust. Thus, the developed gradient RP-HPLC method can be successfully practiced for the routine quality control analysis of Pazopanib Hydrochloride in a pharmaceutical formulation. Top Keywords Pazopanib Hydrochloride, RP-HPLC, Pharmaceutical Formulation, Validation. Top |