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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Stability indicating HPLC method for the quantification of ubidecarenone and piperine simultaneously in tablet formulations

Author: KADALI JAGADEESH, NOWDURI ANNAPURNA
Abstract: In this investigation, a stability indicating HPLC method was presented for the simultaneous determination of ubidecarenone and piperine in bulk and tablets. The ubidecarenone and piperine were analyzed on Agilent C18 column (250 mm length, 4.6 mm identification, 5 µm particle size) using K2HPO4 buffer (0.1M, pH – 3.5): acetonitrile (60: 40, v/v) as the mobile phase. The quantity of ubidecarenone and piperine was quantified by photodiode array detector at 238 nm. The method was validated as per directives given by ICH. The method showed good linearity with R2 = 0.9992 in the concentration range 2.5-7.5 µg/ml for piperine and R2 = 0.9991 in the concentration range 100-300 µg/ml for ubidecarenone. The LOD and LOQ were 0.074 µg/ml and 0.248 µg/ml for piperine, and 0.564 µg/ml and 1.882 µg/ml for ubidecarenone. Tablet solution of ubidecarenone and piperine was exposed to forced degradation by 0.1 N NaOH (alkaline hydrolysis), 0.1N HCl (acidic hydrolysis), distilled H2O (neutral hydrolysis), H2O2 (oxidation), dry heat (thermal degradation) and exposure to sunlight (photo degradation) conditions. The degraded products are resolved well from the peaks of ubidecarenone and piperine with different retention time. The validation results proved that the method is selective, precise, robust and accurate for the estimation of ubidecarenone and piperine simultaneously. The developed stability indicating HPLC method can be applied for the quantitative determination of ubidecarenone and piperine in bulk drug and tablets.
Keyword: Ubidecarenone, Piperine, Degradation, stability, HPLC, Evaluation
DOI: https://doi.org/10.31838/ijpr/2019.11.03.076
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