Determination of 3 Kinds of Constituents in Compound Miconazole Nitrate Cream / 中国药房

ABSTRACT

OBJECTIVE:To establish an HPLC method for determination of triamcinolone acetonide(TA), diphenhydramine hydrochloride(DH) and miconazole nitrate(MN) in compound miconazole nitrate cream(MNC). METHODS: The determination was performed on Hypersil ODS2. The mobile phase consisted of methanol-acetonitrile-0.5% ammonium acetate (45∶35∶20) at a flow rate of 1.0 mL?min-1. The UV detection wavelength was 234 nm; the column temperature was 40 ℃ and the inject volume was 20 ?L. RESULTS: The linear ranges for MN, TA and DH were 0.16～0.64 (r=0.999 8), 0.02～0.06 (r=0.999 9) and 0.08～0.24 (r=0.999 2) mg?L-1 respectively, with their average recoveries at 100.0%, 99.6% and 100.7%, RSD at 1.2%, 0.8% and 0.9%(n=3) respectively. CONCLUSION: The HPLC method can be used for the simultaneous determination of the three constituents in CMNC.