HPLC法测定氨酚比林注射液的含量及有关物质

HPLC determination of the content of paracetamol and aminophenazone injection and its related substances

目的:采用高效液相色谱法测定氨酚比林注射液的含量及有关物质对氨基酚。方法:采用Lichrospher C_(18)(5μm,4.6mm×250 mm)色谱柱,柱温30℃,以甲醇-水-冰醋酸(40:60:0.3)为流动相,流速1.0 mL·min^(-1),检测波长273 nm。结果:在含量测定项下,对乙酰氨基酚在30.08～270.72 μg·mL^(-1)浓度范围内呈良好线性(r=0.9999),平均回收率(n=9)为100.5%;安替比林在37.51～337.57μg·mL^(-1)浓度范围内呈良好线性(r=0.9999),平均回收率(n=9)为99.7%。对乙酰氨基酚、安替比林与对氨基酚分离度良好。结论:该法快速简便,分离度好,结果准确可靠。

Objective：To determine the content and the related substances p - aminophenol of paracetamol and aminophenazone injection by HPLC. Method： HPLC was conducted on a Lichrospher C18 （5 μm,4. 6 mm × 250 mm） column at column temperature of 30 ℃, with methanol - water - glacialacetic acid （40：60： 0. 3 ） as mobile phase and detected with UV 273 nm and a flow rate of 1.0 mL · min^ - 1. Result： The linear range was 30. 08 - 270. 72 μg· m L^- 1 （ r = 0. 9999 ） , the average recovery was 100. 5% （ n = 9 ） for paracetamol. The linear range was 37.51 - 337, 57μg · m L^-1 （ r = 0. 9999 ）, the average recovery was 99.9% （ n = 9 ） for phenazone. Satisfactory separation among paracetamol, phenazone and p - aminophenol was obtained. Conclusion：This method is simple, rapid and reliable.