HPLC法同时测定酮康他索软膏中酮康唑和丙酸氯倍他索的含量

HPLC Determination of Ketoconazole and Clobetasol Propionate in Clonazole Cream

目的:采用高效液相色谱法测定酮康他索软膏中酮康唑、丙酸氯倍他索的含量。方法:色谱柱为Hypersil BDS C_(18)和Kromasil C_(18);流动相为0.02 mol·L^(-1)磷酸氢二钠溶液-甲醇(30:70),并用稀磷酸调节pH至6.9±0.1;紫外检测器,检测波长为239 nm。结果:在建立的色谱条件下,酮康唑及丙酸氯倍他索与有关杂质能有效地分离。酮康唑进样量在3.2～28.8 μg,丙酸氯倍他索在0.08～0.72 μg范围内与峰面积呈良好线性关系,相关系数依次为0.999 7,0.999 9,回收率依次为100.8％,101.3％。结论:本法精密度好,结果准确可靠。

Objective: To determine ketoconazole and clobetasol propionate in clonazole cream by HPLC. Method: Using a Hypersil BDS C18column and Kromasil C18; The mobile phase consisted of 0. 02 mol· L-1 dipotassi-um hydrogen phosphate - methanol ( 30: 70 ) , adjusted to pH 6. 9± 0. 1 with dilute phosphoric acid; detection was at 239 nm. Results: The standard curves for ketoconazole and clobetasol propionate were linear over the ranges of 3. 2 - 28. 8 μg (r= 0. 999 7) and 0. 08 - 0. 72μg ( r = 0. 999 9), respectively. The recoveries of ketoconazole and clobetasol propionate were 100. 8% and 101. 3% ; respectively. Conclusion: The method is good reproducible, and reliable.