摘要
目的:建立高效液相色谱法测定硫酸鱼精蛋白注射液中苯酚含量。方法:采用Inertsil ODS-4(5μm,4.6 mm×250 mm)色谱柱,流动相为甲醇-水(40∶60),流速1.0 m L·min^(-1),检测波长为270 nm;并采用建立的方法考察了不同厂家硫酸鱼精蛋白注射液中苯酚的含量。结果:在上述色谱条件下,苯酚质量浓度在0.050 7~0.355 2 mg·m L^(-1)范围内呈良好的线性,r=0.999 9;平均回收率(n=3)为98.8%~100.8%;样品测定结果为标示值的72%~102%,与采用药典标准方法测定结果基本一致。结论:本文方法经方法学验证可用于硫酸鱼精蛋白注射液苯酚含量的测定。
Objective：To establish an HPLC method for determination of phenol in protamine sulfate preparation.Methods：The sample was analyzed on a Inertsil ODS-4（5 μm,4.6 mm×250 mm）column with the mobile phase of methanol-water（40∶60）;the flow rate was 1.0 m L·min（-1）,and the detection wavelength was 270 nm.Protamine sulfate injections from different manufacturers were detected using the established method.Results：Under the above HPLC conditions,the linear range of the phenol concentration was 0.050 7-0.355 2 mg·m L（-1）,r=0.999 9;and the average recovery（n=3）of phenol was 98.8%-（-1）00.8%.The determination results of phenol in protamine sulfate preparation were 72%-（-1）02% of labeled value,which were basically consistent with the results determined by the pharmacopoeia standard method.Conclusion：This HPLC method can be applied to effective determination of phenol in protamine sulfate preparation,and the method meets the requirements for methodology validation.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2016年第7期1263-1267,共5页
Chinese Journal of Pharmaceutical Analysis
基金
国家十二五"重大新药创制"科技重大专项(2015ZX09303001)
