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VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF FEBUXOSTAT AND DICLOFENAC POTASSIUM IN BULK DRUG AND IN BI LAYER TABLET FORMULATION

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Author(s): Sanghvi Vaibhav | Mahajan Mohit | Rajput Sadhana

Journal: International Research Journal of Pharmacy
ISSN 2230-8407

Volume: 4;
Issue: 9;
Start page: 103;
Date: 2013;
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Keywords: RP-HPLC | Febuxostat | Diclofenac potassium | Validation

ABSTRACT
A simple, rapid, accurate and precise isocratic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for simultaneous estimation of febuxostat and diclofenac potassium in combined dosage form by using phenomenex C18 column (stationary phase) having dimension of 4.6 × 250 mm and particle size of 5 μm and mobile phase containing a mixture of 0.02 M potassium dihydrogen orthophosphate buffer (adjusted to pH 7 with sodium hydroxide): acetonitrile: methanol (35:9:56 v/v/v) at a flow rate of 1 ml/min and detection was carried out at 290 nm. The retention times of febuxostat and diclofenac potassium were 6.01 ± 0.02 minutes and 7.10 ± 0.02 minutes respectively. The developed method was validated as per ICH guideline for specificity, linearity, accuracy and precision, limit of detection and limit of quantification. Linearity studies for the developed method were found in the range of 5 to 30 μg/ml for febuxostat and 12.5 to 75 μg/ml for diclofenac potassium respectively. The accuracy of the method was studied by recovery study and found to be in the range of 98 % - 102 %. The % RSD for intraday and inter day precision was found less than 2. The new RP-HPLC method was successfully applied to marketed formulation of Febuxostat and Diclofenac potassium without any interference from excipients.
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