克霉唑有关物质检查色谱条件的优化

目的：优化并改进克霉唑有关物质检查的色谱条件。方法：比较《中华人民共和国药典》（ChP）、《美国药典》（USP）、《英国药典》（BP）、《欧洲药典》（EP）和《日本药局方》（JP）中克霉唑有关物质的检测方法，通过对各个方法优化，确定最后的色谱条件：色谱柱为Reposil-pur Basic C₁₈（250 mm×4.6 mm，5 μm）；流动相A为磷酸盐缓冲液，流动相B为乙腈，梯度洗脱，流速1.0 mL·min^-1；检测波长210 nm；柱温25℃；进样体积10 μL。结果：有关物质咪唑与溶剂峰能有效分离。结论：本法提高了克霉唑有关物质检查的准确性。 

Objective:To optimize and improve the chromatographic conditions for detecting clotrimazole's related substances. Methods:To compare the detection methods of clotrimazole in Chinese Pharmacopoeia(ChP),United States Pharmacopoeia(USP),British Pharmacopoeia(BP),European Pharmacopoeia(EP)and Japanese Pharmacopoeia(JP). Reposil-pur Basic C₁₈(250 mm×4.6 mm,5 μm)chromatographic column was used for comparison of pharmacopoeia in different countries. The final chromatographic conditions were as follows:the chromatographic column was Reposil-pur Basic C₁₈(250 mm×4.6 mm,5 μm);the mobile phase A was phosphate buffer solution and the mobile phase B was acetonitrile with gradient elution at the flow rate of 1.0 mL·min^-1;the detection wavelength was set at 210 nm;the column temperature was 25℃ and the injection volume was 10 μL. Results:The related substance imidazole and the solvent peak could be separated effectively. Conclusion:This established method improves the accuracy of examination of clotrimazole related substances. 

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