Abstract

SIMULTANEOUS ESTIMATION AND VALIDATION OF TERBINAFINE HYDROCLORIDE AND MOMETASONE FUROATE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

Dipak P. Khatik, R. B. Lawre* and S. D. Mankar

ABSTRACT

The simple, sensitive, rapid, specific, precise, and accurate RP-HPLC method for simultaneous determination of terbinafine hydrochloride and mometasone furoate was developed and validated. Chromatographic separation was achieved on C18 column (250×4.6 mm-5μm p.s) using methanol and water in a ratio (85:15 v/v) as a mobile phase at flow rate of 0.8 ml/min. UV detection was done at 244 nm and injection volum was 20 μl. The peaks obtained were sharp with retention time for terbinafine hydrochloride and mometasone furoate as 6.20 min and 9.38 min respectively. The percentage recoveries obtained were 99.87 % and 99.71% respectively. The proposed method showed good linearity, accuracy, precision and was successfully applied for determination of the drugs in pharmaceutical dosage forms. The current method was statistically validated according to the ICH guidelines and this method was subsequently developed and applied successfully to determine the levels of terbinafine hydrochloride and mometasone furoate in a combined formulation.

Keywords: Terbinafine hydrochloride, Mometasone furoate, RP-HPLC, UV- Spectroscopy.