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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 a method for the determination of phenol in protamine sulfate injection by high performance liquid chromatography. METHODS: Inertsil ODS-4 (5 μm, 4.6 mm × 250 mm) column was used. The mobile phase was methanol-water (40:60) at a flow rate of 1.0 mL · L -1 and the detection wavelength was 270 nm. The established method was used to investigate the phenol content in different manufacturers protamine sulfate injection. Results: Under the above chromatographic conditions, the phenol linearity was linear over the range of 0.050 7 ~ 0.355 2 mg · m L -1, r = 0.999 9. The average recoveries (n = 3) were 98.8% 100.8%. The result of the determination of the sample is 72% ~ 102% of the indicated value, which is basically consistent with the standard method of Pharmacopoeia. Conclusion: The method of this method can be used for the determination of phenol content of protamine sulfate injection by methodological verification.