摘要
目的采用高效液相色谱法测定复方辛伐他汀胶囊中主要成分的含量。方法采用C18柱,柱温45℃,以0.025mol·L-1磷酸二氢钠溶液(pH4.5)-乙腈(7∶13)为流动相,流速为1.0mL·min-1,检测波长分别为辛伐他汀238nm,马来酸依那普利215nm。结果平均回收率分别为辛伐他汀99.92%,RSD=0.40%(n=9);马来酸依那普利100.76%,RSD=0.92%(n=9)。结论该方法简便、灵敏、准确度,适于复方辛伐他汀胶囊的质量控制。
OBJECTIVE To develop a method for the determination of simvastatin and enalapril maleate in Compound Simvastatin Capsule. METHODS The separation was performed on a C18 column. The column temperature was 45℃. The mobile phase was 0. 025mol·L^-1 sodium phosphate mono basic(pH4.5)-- acetonitrile(7 : 13). The flow rate was 1.0mL · min^-1 , The detection wavelength were 238nm for simvastatin and 215nm for enalapril maleate. RESULTS The average recovery for simvastatin was 99.92%,the RSD was 0. 40% ( n =9). The average recovery for enalapril maleate was 100. 76% ,theRSD was 0.92 % ( n = 9). CONCLUSION The method was simple,sensitive and accurate and it was suitable for quantitative detection of Compound Simvastatin Capsule.
出处
《齐鲁药事》
CAS
2009年第2期88-89,共2页
qilu pharmaceutical affairs