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ISSN 2063-5346
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Analytical Method Development And Validation Of Alfacalcidol By Hplc Method

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Arun P, Vijey Aanandhi M, Shanmugasundaram P
» doi: 10.31838/ecb/2023.12.1.340

Abstract

The analytical method development and validation was simple, efficient, and less time-consuming for simultaneous estimation of Alfacalcidol capsules form by HPLC. Chromatographic separation was accomplished in the isocratic mode Mix 920 Volumes of n-Hexane, 40 Volumes of IPA, 40 Volumes of Tetrahydrofuran and 2 Volumes of Acetic acid ( 920:40:40:2) in 1000 mL beaker and Mixed well then sonicate for 5 minutes as the mobile phase by using the column Thermo scientific silica, 250 X 4.6mm, 5µm or equivalent as the stationary phase with a flow rate of 2.0 ml/min using an UV detector maintained at 265nm. The reported periods of retention time of alfacalcidol were found to be 10.9 min . As per ICH guidelines, this procedure has been validated for Specificity, Linearity and Range, Accuracy, System Precision, Method Precision, Intermediate Precision, Robustness, Solution stability and Filter Integrity. Our research focusses on reducing the complexity and duration of time required for analysing alfacalcidol capsules. The results obtained were found to be good and within the limit, proving that the developed method can be used for determination of alfacalcidol.

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