摘要
目的建立测定辛伐他汀乳膏中辛伐他汀含量的超高效液相色谱(UPLC)法。方法色谱柱为ACQUITYUPLCBEHC18柱(100 mm×2.1 mm,1.7μm),流动相为乙腈-水(52∶48,V/V),流速为0.6 mL/min,检测波长为238 nm,柱温为30℃,进样量为5μL。结果辛伐他汀质量浓度在4.132~20.660μg/mL范围内与峰面积线性关系良好(R2=0.9994,n=5);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均回收率为100.20%,RSD为2.20%(n=9)。结论所建立的方法快速,结果准确,可用于辛伐他汀乳膏的质量控制。
Objective To establish an ultra-high-performance liquid chromatography(UPLC)method for the determination of simvastatin in Simvastatin Cream Preparation.Methods The chromatographic column was ACQUITY UPLC BEH C18 column(100 mm×2.1 mm,1.7µm),the mobile phase was acetonitrile-water(52∶48,V/V),the flow rate was 0.6 mL/min,the detection wavelength was 238 nm,the column temperature was 30℃,and the injection volume was 5µL.Results The linear range of simvastatin was 4.132-20.660µg/mL(R2=0.9994,n=5).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rate of simvastatin was 100.20%with an RSD of 2.20%(n=9).Conclusion The established method is rapid and accurate,which can be used for the quality control of Simvastatin Cream Preparation.
作者
余辉
徐楚
陈志明
刘依和
龚春燕
刁义平
YU Hui;XU Chu;CHEN Zhiming;LIU Yihe;GONG Chunyan;DIAO Yiping(Hospital for Skin Diseases,Chinese Academy of Medical Sciences,Nanjing,Jiangsu,China 210042)
出处
《中国药业》
CAS
2023年第16期81-84,共4页
China Pharmaceuticals
