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International Journal of
Pharmaceutical Science and Research
ARCHIVES
VOL. 5, ISSUE 1 (2020)
Analytical method development and validation of stability indicating HPLC method for estimation of pexidartinib in bulk and pharmaceutical dosage form
Authors
Dayawati Anantkumar Jagirdar, Yogesh K Patel, Dhwani A Shah, Bhumi R Patel, Vijay K Patel
Abstract
Stability indicating RP-HPLC method for estimation of Pexidartinib in bulk and pharmaceutical dosage form has been developed. The separation was achieved by Shimadzu LC-10AT Hypersil BDS C18 (25cm x 0.46cm) column and Phosphate Buffer (pH 3.5): Acetonitrile (70:30) as mobile phase at a flow rate of 1.0 mL/min. Detection was carried out at 225 nm. Retention time of Pexidartinib was found to be 6.517 min. The method has been validated for linearity, accuracy and precision. Linearity observed for Pexidartinib 10-30 µg/ml. Developed method was found to be accurate, precise and rapid for estimation of Pexidartinib in bulk and pharmaceutical dosage form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation. Considerable Degradation was found in alkaline degradation. The proposed method was successfully applied for the estimation of the drug in commercial dosage form
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Pages:48-54
How to cite this article:
Dayawati Anantkumar Jagirdar, Yogesh K Patel, Dhwani A Shah, Bhumi R Patel, Vijay K Patel "Analytical method development and validation of stability indicating HPLC method for estimation of pexidartinib in bulk and pharmaceutical dosage form". International Journal of Pharmaceutical Science and Research, Vol 5, Issue 1, 2020, Pages 48-54
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