摘要
目的:建立盐酸多沙普仑注射液的HPLC含量测定及有关物质检查方法。方法:色谱柱为Diamonsil C18(4.6mm×250mm,5μm,迪马公司),流动相为水-甲醇(30:70),流量为1mL·min^-1,检测波长为225nm,柱温为40℃。结果:多沙普仑在20~200mg·L^-1浓度范围内,与峰面积呈良好的相关性(r=0.9995),平均回收率为99.7%(n=9),RSD=1.0%。结论:本法专属性强、灵敏度高、重现性好,结果准确,适用于盐酸多沙普仑注射液的质量控制。
Objective :To establish an HPLC method for content determination and related substances of Doxapram Hydrochloride Injections. Method: Diamonsil C18 column set at 40℃ was used. The mobile phase was watermethanol(30: 70) ,with flow rate 1.0 mL.min^-1 . The wavelength of detection was set at 225nm. Result:A good linearity was obtained over the range of 20 -200 mg . L^-1. The average recovery was 99. 7% (RSD = 1.0%, n = 9 ). Conclusion:The method is accurate and sensitive.
出处
《中国药品标准》
CAS
2009年第2期138-140,共3页
Drug Standards of China