期刊文献+

HPLC法同时测定克霉唑片中多种有关物质 被引量:4

Simultaneous Determination of a Variety of Related Substances in Clotrimazole Tablets by HPLC
下载PDF
导出
摘要 目的:建立HPLC法同时检测克霉唑片中多种有关物质。方法:采用Inert SustainC18色谱柱(4.6 mm×150 mm,5μm),以磷酸二氢钾-四丁基硫酸氢铵溶液为流动相A、乙腈为流动相B,按梯度进行洗脱,流速为1.0 m L·min^(-1),检测波长为210 nm。结果:克霉唑与有关物质A、B、E、F在该色谱条件下均完全分离,在0.08~3.03μg·m L^(-1)浓度范围内克霉唑与峰面积线性关系良好(r=0.9998);有关物质A在0.04~3.42μg·m L^(-1)范围内与峰面积线性关系良好(r=0.9999),平均回收率为99.43%,RSD=1.72%(n=9);有关物质E在0.42~3.58μg·m L^(-1)范围内与峰面积线性关系良好(r=0.9997),平均回收率为100.10%,RSD=1.17%(n=9)。结论:HPLC方法准确、简便、快速,适用于同时测定克霉唑片中多种有关物质。 Objective: To develop an HPLC method for simultaneous determining a variety of relatedsubstances in clotrimazole tablets. Methods: The separation was carried out on an InertSustain- Ctg (4.6mm × 150 mm, 5 μm ) column with a mobile phase of potassium dihydrogen phosphate -tetrabutylammoniumhydrogen sulfate solvent (A) and acetonitrile (B) in gradient, at a flow rate of 1.0 m L-min-1. The detectionwave was set at 210 nm. Results: Clotrimazole was well separated with related substances A , B , E and Funder the above chromatographic conditions. The calibration curve was linear (r=0.9998) within the range of0.08-3.03μg·mL-1 for clotrimazole. The calibration curve was linear (r=0.9999) within the range of 0.043.42μg·mL-1 for related substance A , the average recovery rate was 99.43% with RSD at 1.72% (n =9).The calibration curve was linear (r=0.9997) within the range of 0.42-3.58μg·mL-1 for related substance E ,the average recovery rate was 100.10% with RSD at 1.17% (n=9). Conclusion: This method can be usedto simultaneously separate and determine clotrimazole and a variety of related substances in clotrimazoletablets. It is accurate, simple and fast.
出处 《药学与临床研究》 2016年第4期315-317,共3页 Pharmaceutical and Clinical Research
关键词 克霉唑 HPLC法 有关物质 Clotrimazole HPLC Related substance
  • 相关文献

二级参考文献2

共引文献5

同被引文献20

引证文献4

二级引证文献14

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部