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目的:建立HPLC法测定生脉注射液中聚山梨酯80含量,并与分光光度法测定结果进行比较。方法:采用TSKgeL G2000SWXL(300 mm×7.8 mm,5μm)色谱柱;流动相为0.02 mol·L~(-1)乙酸铵-乙腈(90∶10);流速为0.6 ml·min~(-1);柱温为30℃;ELSD检测条件:漂移管温度110℃,氮气流速2.3 L·min~(-1)。结果:聚山梨酯80在4.046~20.230μg范围内呈良好的线性关系(r=0.997 6),平均回收率为98.9%,RSD为2.7%(n=9)。HPLC法与分光光度法测定结果的差异无统计学意义(P>0.05)。结论:HPLC法操作简便,重复性好,结果准确可靠,可用于聚山梨酯80含量控制。
OBJECTIVE: To establish a HPLC method for the determination of polysorbate 80 in Shengmai injection and compare the results with spectrophotometry. Methods: The chromatographic column TSKgeL G2000SWXL (300 mm × 7.8 mm, 5 μm) was used. The mobile phase was 0.02 mol·L -1 ammonium acetate - acetonitrile (90:10) and the flow rate was 0.6 ml · min -1 The column temperature was 30 ℃. The ELSD conditions were as follows: drift tube temperature 110 ℃, flow rate of nitrogen 2.3 L · min -1. Results: Polysorbate 80 had a good linearity (r = 0.997 6) in the range of 4.046-20.230 μg with an average recovery of 98.9% and a RSD of 2.7% (n = 9). There was no significant difference between HPLC and spectrophotometry (P> 0.05). Conclusion: The HPLC method is simple, reproducible and accurate. It can be used for the control of polysorbate 80 content.