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Determination of mometasone furoate by HPLC in topical preparations: Validation

Ajay Vairale, V.Aniruddha Sherikar, V.Hima Bindu, P.Sivaswaroop

Asimple and rapid high performance liquid chromatographic (HPLC) separationmethod has been developed for determination ofmometasone furoate in topical pharmaceutical preparations. The method was based on high performance liquid chromatographic separation of the mometasone furoate on reversed phase, Hypersil ODS column [C18(3,10cm4.6mm, I.D)] at 30C usingmobile phase consisting of acetonitrile :water:trifluroacetic acid, 500:500:1, v/v. The flow rate was 1.0ml min-1 with an average operating pressure of 89.63 bar. The retention time (tR) was found to be 9.00.9 minutes. Extraction of the analyte from the sample is done with tetrahydrofuran. It was then diluted with mobile phase to achieve the concentration of 10gml-1. Quantitationwas achieved withUVdetection at 254 nmbased on peak area with linear calibration curves at concentration range 2.5-15gml- 1.When the method was applied successfully to topical preparations (Lotions, cream and ointment), no interference from the lotion, ointment and cream excipients were found. The method was validated as per ICH guidelines in terms of precision, robustness, recovery and linearity.