Abstract

MODIFIED UPLC METHOD FOR DETERMINATION OF MICONAZOLE NITRATE AND ITS RELATED PRODUCTION IMPURITIES FROM BULK USING TWO COMPONENT MOBILE PHASE

Asma A. Mokashi*, Varsha K. Jaragb, Rajendra. Doijad and Ahad J. Pathan

ABSTRACT

A rapid, specific, sensitive and precise isocratic modified UPLC method was developed for determination of miconazole nitrate and its associated impurities. The separation was carried out using a Waters Acquity BEH column (50 mm, i.d., 2.1 mm, 1.7 μm) within a short runtime of 9 min using a mobile phase of ammonium acetate buffer–acetonitrile (65:35, v/v), at a flow rate of 0.4 mL/min at an ambient temperature. Quantification was achieved with photodiode array detection at 220 nm. Comparison of system performance with conventional HPLC method was made with respect to analysis time, efficiency and sensitivity. The method was validated according to ICH guidelines with respect to precision, accuracy, linearity, specificity, robustness and limits of detection and quantification.; all parameters examined are found to be well within the stated guidelines and was applied successfully for the estimation of miconazole nitrate and related substance.

Keywords: miconazole Nitrate, UPLC, ICH, HPLC.