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目的:探讨研究高效液相色谱法测定复方替硝唑栓剂中替硝唑和克霉唑的含量。方法:色谱柱:Agilent TC~C18柱(4.6×150 mm,5μm,Agilent),流动相:甲醇~水(58﹕42,用磷酸调至PH 3.5),流速为1.0mL·min~1,检测波长为280nm,进样量为10ul。结果:替硝唑、克霉唑分别在25.0ug·mL~1~400ug·mL~1、12.5ug·mL~1~200ug·mL~1范围内线性关系良好;精密度和重现性均为良好;平均加样回收率分别为98.74%和99.56%;供试品溶液室温放置8小时,2组分均为稳定。结论:本研究所得方法操作简单、快速,专属性高、重现性好,可准确测定复方替硝唑栓剂中替硝唑和克霉唑的含量,用于复方替硝唑的质量控制。
Objective: To study the determination of tinidazole and clotrimazole in compound tinidazole suppository by high performance liquid chromatography. Methods: The mobile phase consisted of methanol and water (58:42, adjusted to pH 3.5 with phosphoric acid) on a column of Agilent TC ~ C18 (4.6 × 150 mm, 5 μm, Agilent) at a flow rate of 1.0 mL · min ~ Wavelength of 280nm, injection volume of 10ul. Results: The calibration curves of tinidazole and clotrimazole were good in the range of 25.0ug · mL -1 ~ 400ug · mL -1, 12.5ug · mL -1 ~ 200ug · mL -1, respectively. The precision and reproducibility were Good; the average recovery rate was 98.74% and 99.56%; for the test solution was placed at room temperature for 8 hours, 2 components were stable. Conclusion: The method obtained in this study is simple, rapid, specific and reproducible. It can accurately determine the content of tinidazole and clotrimazole in the compound tinidazole suppository for the quality control of compound tinidazole.