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目的:建立RP-HPLC法测定克霉唑含量的高效液相色谱法。方法:采用Kromasil ODS-1 C18柱(250 mm×4．6 mm,5 μm),以十八烷基键合硅胶为填充剂,甲醇-磷酸氢二钾溶液(3:1)为流动相,(磷酸氢二钾溶液:取磷酸氢二钾4．35 g以水溶解稀释至1000 ml),流速约为1．0 ml·min-1,检测波长为260 nm。结果:克霉唑在0．14-0．26 mg·ml-1的浓度范围内线性关系良好(r=0．999 0)。克霉唑溶液的平均回收率为100．9％。结论:该法快速、简单、准确,可作为该制剂的质量控制方法。
Objective: To establish a RP-HPLC method for the determination of clotrimazole content by high performance liquid chromatography. Methods: Kromasil ODS-1 C18 column (250 mm × 4.6 mm, 5 μm) was used. The octadecyl-bonded silica gel was used as the filler and methanol-potassium hydrogen phosphate solution (3: 1) (Dipotassium hydrogen phosphate solution: Take dipotassium hydrogen phosphate 4.35 g dissolved in water diluted to 1000 ml), the flow rate of about 1.0 ml · min-1, the detection wavelength was 260 nm. Results: Clotrimazole had good linearity (r = 0.999 0) in the range of 0.14-0.26 mg · ml-1. The average recovery of clotrimazole solution was 100.9%. Conclusion: The method is rapid, simple and accurate and can be used as quality control method of the preparation.