RP-HPLC法测定克霉唑乳膏的含量和有关物质

RP-HPLC determination of content and related substances of clotrimazole cream

目的建立反相高效液相色谱法测定克霉唑乳膏含量及其有关物质。方法色谱柱为Waters C18（150cm×4．6mm，5μm），流动相为0．05mol／L磷酸二氢钾一甲醇（3：7）用稀磷酸调pH值至5．7-5．8，测定波长为215nm，流速为1．5mL／min，柱温为30。结果克霉唑在10．62～106．2Mg／mL浓度范围内线性关系良好（r=0.9999），平均回收率为100．11％，RSD=0．89％（n=9）。有关物质含量少于1％。结论该方法准确、简便、快速、可靠，能有效控制克霉唑乳膏的质量。

Objective To establish an HPLC method for detecting content and related substances of clotrimazole cream. Methods Waters Cls column （4.6mm×150mm, 5μm） was used, and the mobile phase was 0.05mol/L potassium dihydrogen phosphate solution-methanol solution （3：7）, adjusted pH value to 5.7-5.8 with 10% solution of phosphoric acid, column temperature was 30℃, at a flow rate of 1.5mL/min and detection wavelength of 215nm. Results The linear range of clotrimazole was 10.62-106.2pg/mL （r=0.9999）. The average recovery of clotrimazole was 100.11%, RSD=0.89%（n=9）. The content of related substances were less than 1%. Conclusion The method is accurate, simple, rapid and suitable for the quality control of clotrimazole cream.