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Stability Indicating RP-HPLC Method Development and Validation for the Determination of Ivacaftor in Bulk and its Pharmaceutical Formulation
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| Author:
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TANUJA , S. GANAPATY, VARANASI S N MURTHY
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| Abstract:
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The focal objective of the present work is to establish and validate a novel and experimental stability-indicating isocratic RP-HPLC method for Ivacaftor quantitative evaluation in bulk and marketed formulations. Using the mobile step of composition 0.2 percent Trifluoroacetic acid buffer: acetonitrile in a ratio of 40:60 v / v, the assessment of the subject drug was accomplished with a column Xbridge C18 (4.6 x 150 mm, 5 µm). A variable wavelength UV detector at a wavelength of 225 nm controlled the flow rate of 1.0 ml/min with the injection volume of 20 µL. Ivacaftor had a holding time of 2.31 min, respectively. The validation of the proposed method was performed in compliance with the guidelines set out in the International Conference on Harmonisation. For Ivacaftor this approach is linear over a range of 10-50 µg / ml. The developed method is reproducible and precision has been found within the specification. Ivacaftor's Assay was obtained at 100.26 percent, respectively. Studies of stress degradation were performed and as no degradation compounds were detected the proposed method was found to be accurate. The existing approach has, therefore, been found to be accurate for routine research.
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| Keyword:
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Ivacaftor, Reverse-phase, liquid chromatography, Validation, Mobile phase, Degradation studies
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.011
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| Download:
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