HPLC法测定不同厂家联苯苄唑凝胶的含量

Content Determination of Bifonazole Gel from Different Manufacturers by HPLC

目的：考察不同厂家联苯苄唑凝胶的质量。方法：采用高效液相色谱法。色谱柱为Diamonsil C18,流动相为甲醇-水-四氢呋喃（75∶24∶1,V/V/V）,流速为1.0 ml/min,检测波长为254 nm,柱温为23℃,进样量为10μl。结果：联苯苄唑检测质量浓度线性范围为50-600μg/ml（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈1%;加样回收率为97.71%-101.68%,RSD=1.16%（n=9）。三厂家生产的联苯苄唑凝胶样品含量均达10 mg/g以上,其差异不大。结论：该方法简便、准确、分离度和重复性好,适用于联苯苄唑凝胶的含量测定。所考察的不同厂家产品含量均符合相关标准的要求。

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 of1.0 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 μ g/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.