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Development and validation of normal phase HPTLC method for simultaneous quantification of Mometasonefuroate and Terbinafine hydrochloride in cream dosage form | Abstract
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Abstract

Development and validation of normal phase HPTLC method for simultaneous quantification of Mometasonefuroate and Terbinafine hydrochloride in cream dosage form

Author(s): Pravin D. Pawar, Satish Y. Gabhe and Kakasaheb R. Mahadik

Present research work describes a simple, precise and accurate method for simultaneous estimation of Mometasonefuroate and Terbinafine hydrochloride in cream dosage forms by high performance thin layer chromatographic method. Chromatographic development of standard and samples were carried out on Merck aluminium plates precoated with silica gel 60 F254 as the stationary phase. Mobile phase used was n-hexane: ethyl acetate: acetic acid (7.5:3:0.5 v/v/v). UV wavelength selected for the detection was 258nm in reflectance/absorbance mode. The retardation factors were found to be 0.27±0.02 and 0.74±0.02 for Mometasonefuroate and Terbinafine hydrochloride, respectively. Developed method was validated as per ICH Q2 (R1) guidelines. Linearity range for Mometasonefuroate was found to be 50-450 ng band-1 (r2=0.9994) and that of Terbinafine hydrochloride was found to be 400-3600 ng band-1(r2=0.9989). Linearity was also confirmed by residual analysis which showed no tendency in the residual plot. The formulation analyzed was found to contain 0.098 ± 0.001 % (w/w) of MTS and 1.01 ± 0.005% (w/w) of TBF with recovery of 98.79 and 101.05 % for MTS and TBF, respectively. This developed and validated method is new simple approach for simultaneous quantitative estimation of Mometasonefuroate and Terbinafine hydrochloride in pharmaceutical formulations.