OBJECTIVE: To evaluate the quality of Bifonazole Gel from different manufacturers. METHODS: HPLC was performed on the column of Diamonsil C18 with mobile phase of methanol - water - tetrahydrofuran (75 ∶ 24 ∶ 1,V/V/V) at a flow rate of 1.0 ml/min, detection wavelength was 254 nm, column temperature was 23 ℃, and the injection volume was 10 μl. RESULTS: The linear range of bifonazole was 50-600 μg/ml (r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 1%; recovery was 97.71%-101.68% (RSD=1.16%,n=9). The contents of Bifonazole gel samples from 3 manufacturers were more than 10 mg/g, with little difference. CONCLUSIONS: The method is simple and accurate with good separation and reproducibility, and suitable for the content determination of Bifonazole gel. The investigated contents of products from different manufactures conform to relevant standards.
关键词
联苯苄唑凝胶高效液相色谱法含量测定市售产品质量
Keywords
Bifonazole gelHPLCContent?determinationCommercially available productsQuality