丙酸氯倍他索乳膏中多种有机溶剂的分析研究  

Analysis and Study of Various Organic Solvents in Clobetasol Propionate Cream

作　　者：唐立超 郑淑凤 王亚君 许永彬 TANG Lichao;ZHENG Shufeng;WANG Yajun;XU Yongbin(Xiamen Institution for Food and Drug Quality Control,Xiamen Fujian 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361012

出　　处：《药品评价》2024年第9期1056-1059,共4页Drug Evaluation

摘　　要：目的建立气相色谱法同时测定丙酸氯倍他索乳膏中23种有机溶剂的含量,分析国产丙酸氯倍他索乳膏中溶剂残留情况。方法以甲醇为溶剂,超声提取丙酸氯倍他索乳膏中的有机溶剂,采用气相色谱法,直接进样,程序升温分离各组分,并用FID检测器进行测定。结果23种有机溶剂线性关系良好(r≥0.9990),精密度RSD为1.1%~6.2%(n=6),加样回收率在87.7%~102.9%之间。测定161批次乳膏,结果检出乙醇量为0.29%~3.9%,丙酮量为0.80%~1.2%,丙二醇量为0.44%~7.9%,二甲基亚砜量为0.51%~1.0%。结论建立的气相色谱法操作简便、结果准确、方法灵敏,所覆盖的有机溶剂种类达23种,适用于丙酸氯倍他索乳膏中多种残留溶剂的同时筛查检测。Objective To establish a gas chromatography method for simultaneous determination of 23 organic solvents in clobetasol propionate cream and analyze the solvent residue in domestically produced clobetasol propionate cream.Methods The organic solvents in clobetasol propionate cream were extracted by sonication using methanol as the solvent.With temperature programming and direct injection,the components were separated by the GC and tested by FID detector.Results The calibration curve of each solvent showed good linear correlation(r≥0.9990).The RSD of precision was 1.1%~6.2%(n=6).The average recovery was in the range of 87.7%~102.9%.161 batches of cream samples were tested and analysed.The ethanol,acetone,propylene glycol,and dimethyl sulfoxide were found,and the results of these organic solvents were 0.29%-3.9%,0.80%~1.2%,0.44%~7.9%and 0.51%~1.0%,respectively.Conclusion The developed gas chromatography method is characterized by its operational simplicity,while also good accuracy and sensitivity in the analytical detection of targeted compounds.This method encompasses 23 organic solvents and is suitable for the screening and testing of various residual solvents in clobetasol propionate cream.

关 键 词：丙酸氯倍他索乳膏 有机溶剂 气相色谱法 FID检测器 

分 类 号：R28[医药卫生—中药学]