【摘要】 目的:建立反相高效液相色谱法测定克霉唑阴道泡腾片含量及其有关物质。方法:采用 Thermo C₁₈（250 mm×4.6 mm,5μm）色谱柱,以磷酸盐缓冲溶液（取磷酸氢二钾4.35 g,用水适量溶解并稀释至1000 mL）-甲醇（22.5:77.5）为流动相;检测波长254 nm,流速1.0 mL·min^-1,按峰面积外标法计算。结果:克霉唑在50.0～1000.0μg·mL^-1浓度范围内呈良好的线性关系（r=0.9994）,方法回收率为99.3%～100.6%（n=5）,克霉唑含量在99.9%～104.2%之间,有关物质含量少于0.79%。结论:本方法简便、快速,结果准确、可靠,重现性好,所测该药含量及有关物质均在合格范围之内。更多还原

【Abstract】 Objective:To establish an HPLC method for the determination of content and related substances of clot- rimazole vaginal effervescent tablets.Method:A Thermo C₁₈（250 mm×4.6 mm,5 μm） column was used.The mo- bile phase composed of buffer（ dipotassium hydrogen phosphate 4.35 g duilt water to 1000 mL）-methanol（22.5: 77.5）.Detection wavelength was 254 nm,flow rate was 1.0 mL·min^-1.Results:The linearity of the calibration curvewas well correlated （r=0.9994） within the range of 50.0-1000.0 μg·mL^-1.The recovery was 99.3%- 100.6% （n=5）.The content of related substances were less than 0.79%.Conclusion:The method is simple,rap- id ,results are aeeuate and good reproducible,The content and related substances of elotrimazole vaginal effervescent tablets are both within acceptable range.更多还原