丙酸氯倍他索尿素乳膏中尿素的含量测定方法研究

Study on Method for Determination of Urea in Clobetasol Propionate Urea Cream

目的:建立和考察丙酸氯倍他索尿素乳膏中尿素含量的高效液相色谱法(high performance liquid chromatography,HPLC)测定方法。方法:分别以NH_(2)柱和SB-Aq柱作为测定柱,采用HPLC法测定丙酸氯倍他索尿素乳膏中尿素的含量,并考察其方法的线性关性、精密度、稳定性、重复性、回收率等。结果:(1)采用NH_(2)柱测得乳膏中尿素浓度为0.2022~5.0540μg/mL(r^(2)=0.9999)时呈良好的线性关系,平均加样回收率为97.95%,相对标准偏差(relative standard deviation,RSD)为0.50%(n=6),测得尿素的平均含量为98.15%;(2)采用SB-Aq柱测得乳膏中尿素浓度为0.5904~5.9040μg/mL(r^(2)=0.9998)时也有良好的线性关系,平均加样回收率为98.66%,RSD为0.89%(n=6),测得尿素的平均含量为98.97%。结论:NH_(2)柱和SB-Aq柱两种测定方法测得乳膏中尿素含量均无显著性差异,且操作方法简便、准确,重现性好,均可用于丙酸氯倍他索尿素乳膏的质量控制。

Objective:To establish and investigate a high performance liquid chromatography(HPLC)method for the determination of urea content in clobetasol propionate urea cream.Methods:The content of urea in clobetasol propionate urea cream was determined by HPLC(NH_(2) column and SB-AQ column),and the linearity,precision,stability,repeatability and recovery of the method were investigated.Results:(1)The average recovery was 97.95%,RSD was 0.50%(n=6),and the average urea content was 98.15%.When the concentration of urea in the cream was between 0.2022 and 5.0540μg/mL(r^(2)=0.9999)by NH_(2)column,the linear relationship was good.(2)The linear relationship was also good when the concentration of urea in the cream was between 0.5904 and 5.9040μg/mL(r^(2)=0.9998)by SB-AQ column.The average recovery was 98.66%,RSD was 0.89%(n=6)and the average urea content was 98.97%.Conclusion:There is no significant difference in urea content measured by NH_(2)column and SB-AQ column,and the methods are simple,accurate and reproducible,which could be used for the quality control of clobetasol propionate urea cream.