HPLC法测定复方克霉唑乳膏中氯甲酚的含量

HPLC法测定复方克霉唑乳膏中氯甲酚的含量

彭博,董斌,丁红雨,邹亮

大连市药品检验所,大连市药品检验所,大连市药品检验所,大连市药品检验所

收稿日期:2017-03-01 修回日期:2017-03-01 出版日期:2017-02-25 发布日期:2017-01-25

Determination of Chlorocresol in Compound Clotrimazole Cream by HPLC

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Received:2017-03-01 Revised:2017-03-01 Online:2017-02-25 Published:2017-01-25

摘要/Abstract

摘要： 目的：建立HPLC法测定复方克霉唑乳膏中氯甲酚的含量。方法：使用Waters Xbridge-C18(4.6 mm×250 mm，5 μm)色谱柱；以0.05 mol?L-1磷酸二氢钾溶液（用2 mol?L-1氢氧化钾溶液调节pH值为5.7±0.05）为流动相A，乙腈-甲醇（1∶1）为流动相B，梯度洗脱；柱温35℃；检测波长为280 nm；流速为1.0 mL?min-1。结果：氯甲酚在10.407~31.222 μg?mL-1(r=0.9990)范围内线性关系良好，平均加样回收率为99.5%，RSD为0.75%（n=9）。结论：该方法简便，准确，重复性好，可用于复方克霉唑乳膏的质量控制。

Abstract: Objective： To establish an HPLC method for determination of chlorocresol in compound clotrimazole cream.Methods： HPLC method was carried on with a Waters Xbridge-C18 (4.6 mm×250 mm， 5 μm) column， using a gradient method for mobilephase， a mixture of a 0.05 mol?L-1 potassium dihydrogen phosphate solution(pH adjusted to 5.7 with 2 mol?L-1 potassium hydroxide solution) as the mobile phase A， acetonitrile-methanol (1∶1) as the mobile phase B.Detection wavelength was set at 280 nm， the flow rate was 1.0 mL?min-1， and the column temperature was 35 ℃.Results：The calibration curves were linear in the range of 10.407~31.222 μg?mL-1(r=0.9990) for chlorocresol.The average recovery rate was 99.5% with RSD 0.75%(n＝9). Conclusion：The method is convenient， accrate with a good reproducibility， and suitable for quality control of compound clotrimazole cream.

彭博,董斌,丁红雨,邹亮. HPLC法测定复方克霉唑乳膏中氯甲酚的含量[J]. .