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A Novel Validated Gradient Hplc Method For Analysing Axitinib And Their Process Related Impurities By Pda Detection
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| Author:
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SHYAMALA, D.ASHOK, P.SHYAM
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| Abstract:
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Objectives: The present study mainly intends to develop validated stability indicating method for separation and estimation of axitinib and their process related impurities by Reverse Phase HPLC method.
Methods: Axitinib and its three process related impurities (Impurity 1, Impurity 2 and Impurity 3) were efficiently separated on nonpolar standard discovery C8 (250mm x 4.6mmx 5µm) column using mobile phase 0.1% of orthophosphoric(A) acid and methanol(B) on gradient elution. The wavelength for determination of impurities was set at 235nm by PDA detection with flow rate 1ml/min.
Results: The resulted chromatograms were examined to be linear and sensitive over the range 0.25-1.5µg/ml for drug and its impurities. Recovery of impurities was found to be in the range of 99-101%. The relative response factors for all three impurities were calculated by slope method. Recovery studies, precision, detection limits and robustness were determined by statistical calculations. No significant degradation was observed during stability studies.
Conclusion: The evaluated method was found to be novel and rapid not only applicable for qualitative analysis of axitinib in bulk and drug development process but also for detection of impurities in tablet formulation.
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| Keyword:
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Axitinib, process related impurities, HPLC, stability indicating, Relative response factor
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.107
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| Download:
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