Development and Validation of Analytical Method for Simultaneous Estimation of Tazarotene and Hydroquinone in their Gel Formulation by Reversed-phase High Performance Liquid Chromatography

Abstract

A simple, sensitive, rapid, precise and accurate method has been developed for simultaneous estimation of tazarotene and hydroquinone in their pharmaceutical dosage form (gel preparation). The chromatographic separation was carried out on a reversed-phase Inertsil C18 (4.6 mm I.D. × 250 mm, 5 μm) column using a mobile phase consisting of 0.02 M KH2PO4‒acetonitrile (80 : 20, v/v) at a flow rate of 1.0 mL/min and UV detection at λmax = 254 nm. The method showed linearity with the correlation coefficient of 0.999 for both tazarotene and hydroquinone over the concentration range of 5‒25 and 1‒5 µg/mL, respectively. The mean recoveries were found to be in the range of 98‒101% for both components. The method was validated as per International Conference on Harmonization guidelines for linearity, limit of detection, limit of quantification, specificity, accuracy, precision and robustness. As a result, this method can be successfully applied for routine quantification of tazarotene and hydroquinone in pharmaceutical dosage form (gel preparation).