Open AccessDevelopment and Validation of a Stability-Indicating Method for the Determination of Pazopanib Hydrochloride by RP-HPLC
Author(s) -
P. Ravisankar,
Malini Satya,
A. Bhavani Sailu,
Sk. Rijwana,
Kamma Harsha Sri,
K. Sree Pujitha
Publication year - 2021
Publication title -
international journal of pharmaceutical sciences review and research
Language(s) - English
Resource type - Journals
ISSN - 0976-044X
DOI - 10.47583/ijpsrr.2021.v68i01.035
Subject(s) - chromatography , high performance liquid chromatography , pazopanib , chemistry , medicine , renal cell carcinoma , oncology , sunitinib
A precise, accurate, highly sensitive, rapid, and reproducible stability HPLC method was developed and validated for the estimationof Pazopanib Hydrochloride (PAZO) in bulk and tablet dosage form. Decent quality chromatographic separation of PazopanibHydrochloride was done by using Eclipse plus C18 column (4.5 mm i.e. X 150 mm, 3.5µm particle size) (based on 99.99 % ultra-highpurity silica) using mobile phase that containing 0.1 % Orthophosphoric acid: Acetonitrile (55:45 % v\v) at a flow rate of 1.0 mL/minute. The wavelength ?max of PAZO used for the detection was found to be 271.4 nm. The retention time for Pazopanib was found to 1.43 minutes. The PAZO was linear in the concentration range of 2-10 µg/mL (r2 = 0.9999) for HPLC method. The regression equation for PAZO was found to be Y = 700955 x + 28022 for HPLC. The LOD and LOQ were found to be 0.1675 ?g/mL, 0.0552 µg/mL for the 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 PAZO was found to be 99.85 ± 1.2, which was in good agreement with the labeled claim. Pazopanib was subjected to stressed conditions like acidic, basic, oxidative, photolytic, and thermal conditions. The degradation results were found satisfactory. The developed gradient RP-HPLC method can be successfully practiced for the routine quality control analysis of PAZO in pharmaceutical tablets and routine quality control analysis.