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目的建立HPLC法测定复方克霉唑乳膏中克霉唑和二丙酸倍他米松的含量。方法使用waters sysmmetry 4.6*250mm 5um色谱柱;以0.05mol/L磷酸氢二氨(用85%磷酸调节p H值为7.0±0.05)为流动相A,甲醇为流动相B,按A:B=3:7进行洗脱,流速:1.0m L/min;检测波长:254nm;柱温:30℃;进样量:20μL。结果克霉唑在104.894μg/m L~1048.94μg/m L(r=0.9990),二丙基倍他米松在5.2629μg/m L~26.3145(r=0.9990)范围内均线性关系良好。结论该方法简便,准确,重复性好,可用于同时检测复方克霉唑乳膏中的克霉唑和二丙酸倍他米松的含量。可用于乳膏制剂的质量控制。
Objective To establish an HPLC method for the determination of clotrimazole and betamethasone dipropionate in compound clotrimazole cream. Methods Waters sysmmetry 4.6 * 250mm 5um column was used. Mobile phase A was 0.05mol / L diammonium phosphate (pH = 7.0 ± 0.05 with 85% phosphoric acid), methanol was mobile phase B, 3: 7 elution, flow rate: 1.0m L / min; detection wavelength: 254nm; column temperature: 30 ℃; injection volume: 20μL. Results Clotrimazole had a good linear relationship in the range of 104.894μg / m L to 1048.94μg / m L (r = 0.9990) and dipropyridamonide in the range of 5.2629μg / m L to 26.3145 (r = 0.9990). Conclusion The method is simple, accurate and reproducible. It can be used for the simultaneous determination of clotrimazole and betamethasone dipropionate in compound clotrimazole cream. Can be used for the quality control of cream preparations.