Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC AND HPTLC METHODS FOR SIMULTANEOUS ESTIMATION OF MOMETASONE FUROATE AND MICONAZOLE NITRATE IN CREAM FORMULATION

Khushali A. Shah* and Jayant B. Dave

ABSTRACT

Two methods are described for the simultaneous determination of Mometasone Furoate (MOM) and Miconazole Nitrate (MIC) in cream formulation. The first method was based on HPTLC separation of the two drugs followed by densitometric measurements at 230 nm. The separation was carried out on aluminium plates precoated with silica gel 60F-254 as the stationary phase using hexane:chloroform:methanol:ammonia (6:3:1:0.1 v/v/v/v) as mobile phase. The system was found to give good resolution with Rf value of MOM and MIC was 0.21 and 0.62 respectively at 230 nm. The linear regression analysis data for the calibration plots of MOM and MIC showed good linear relationship with r2 value of 0.9989 and 0.9987 respectively in the concentration range of 400-1200 ng/band for MOM and 8000-24000 ng/band for MIC. The second method was based on HPLC separation of two drugs on the reversed phase ACE column C18 (150 mm x 4.6 mm, 5 μm) at ambient temperature using Acetonitrile:Water (80:20 v/v) as mobile phase , flow rate of 0.6 mL/min and wavelength of 229 nm. Method was found to be linear with concentration range of 2-7 μg/mL and 40-140 μg/mL for MOM and MIC respectively. No interference was found from the chlorocresol used as preservative. Both the methods were validated as per ICH guidelines and applied for simultaneous estimation of Mometasone Furoate and Miconazole Nitrate in cream formulation.

Keywords: Mometasone Furoate, Miconazole Nitrate, HPTLC, RP-HPLC, cream.