A New Stability Indicating Assay Method for the Quantitative Determination of Topiroxostat in Bulk and Dosage Form

Authors

Abstract

 Topiroxostat is a novel xanthine oxidoreductase (XOR) inhibitor used to treat hyperuricemia and gout. The main objective of the present work was to develop an authentic, rapid, and reliable reverse phase –high performance liquid chromatography (RP-HPLC) method for assessing topiroxostat and determining its stability in both API and tablet. The analysis was carried out on an Agilent Zorbax bonus RP C18 column (250 x 4.6 mm, 5 µm) at 30°C in isocratic mode with a mobile phase 50mM/L potassium dihydrogen phosphate (pH 3.3 corrected with orthophosphoric acid): acetonitrile (20:80 v/v) at a flow rate of 1 mL/min and a wavelength of 272 nm The linearity and range, accuracy, precision, LOD, LOQ and robustness of the proposed method were validated according to the ICH guidelines, and the findings were satisfactory. This study was conducted under various stress conditions such as acidic, basic, oxidative, photolytic, and thermal conditions. The retention time was found to be 6.99 min; the linearity range was 0.01-120µg/mL. The developed method has a very sensitive detection limit of 0.075 µg/mL and a quantitation limit of 0.229 µg/mL for topiroxostat. Thus this method can be successfully employed for topiroxostat analysis without any interference with the excipients used in dosage form. 

Keywords:

Topiroxostat, RP-HPLC, Stability- indicating, ICH, hyperuricemia

DOI

https://doi.org/10.25004/

References

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Published

30-01-2025
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“A New Stability Indicating Assay Method for the Quantitative Determination of Topiroxostat in Bulk and Dosage Form”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 17, no. 1, Jan. 2025, https://doi.org/10.25004/.

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Research Article

How to Cite

“A New Stability Indicating Assay Method for the Quantitative Determination of Topiroxostat in Bulk and Dosage Form”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 17, no. 1, Jan. 2025, https://doi.org/10.25004/.

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