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Bioanalytical Method Development and Validation for Quantification of Fexofenadine Hydrochloride and Piperine in Human Plasma by RP-HPLC
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| Author:
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, PANKTI PATEL, GOPI PATEL, DEVANG TANDEL, KALPANA PATEL, RAJESH PARMAR, AKSHAY SHAH, TEJAL GANDHI
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| Abstract:
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A appropriate bioanalytical approach needed to be developed for quantification of Fexofenadine HCl and Piperine in Human Plasma. This study presents the validation and optimization of a sensitive reverse phase liquid chromatographic bio analytical technique for the measurement of fexofenadine hydrochloride in plasma containing piperine. Separation was achieved using a Phenomenex C18 (250 × 4.60 mm, 5µm) column and mobile phase composed of methanol: water with using trifluoroacetic acid as a modifier in a ratio of 65:35 (% v/v) showing retention time 5.1 min, 6.3 min and 12.5 min for Fexofenadine HCl, internal standard and Piperine respectively with a flow rate 1.0 ml/min. Protein precipitation sample extraction method showed extraction recovery >90% for fexofenadine HCl and piperine from plasma. This optimized extraction method gave clear samples and showed a good linear relationship between peak area ratio and concentration range from 0.32 - 3.0µg/ml for fexofenadine HCl and 0.32-6.25µg/ml for piperine. The pharmacokinetic analysis demonstrated a higher plasma concentration time profile for the formulation in comparison to the pure drug and market formulation, demonstrating the improved absorption profile of fexofenadine HCl. The established developed method was used to the estimation of fexofenadine HCl alone and in combination with piperine on oral administration in female albino rats, and it was verified in accordance with guidelines. This chromatographic technique demonstrated quick analytical times, improved extraction recovery, good linearity, and good quantification.
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| Keyword:
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Piperine, Bioavailability, Pharmacokinetic, RP-HPLC, Plasma
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2025.17.01.008
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| Download:
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