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目的:建立HPLC法测定复方苦参注射液中增溶剂聚山梨酯80的含量。方法:样品和1 mol·L~(-1)的KOH溶液混合后,在70℃水解3 h,聚山梨酯80定量水解出油酸,采用HPLC法测定。色谱条件:Eclipse XDB-C_(18)色谱柱(150 mm×4.6 mm,5μm);磷酸二氢钾缓冲液(用85%磷酸调pH至2.8)-乙腈(80:20)为流动相,流速1.0 ml·min~(-1),检测波长200 nm,柱温:30℃。结果:聚山梨酯80在0.5～20 mg·ml~(-1)范围内线性关系良好(r=0.999 2);回收率为100.8%,RSD为2.8%(n=9)。结论:所建立的HPLC方法准确、快速,可用于复方苦参注射液中聚山梨酯80的含量测定。
Objective: To establish an HPLC method for the determination of polysorbate 80 in Compound Kushen Injection. Methods: After the sample was mixed with 1 mol·L -1 KOH solution and hydrolyzed for 3 h at 70 ℃, polysorbate 80 was hydrolyzed to produce oleic acid by HPLC. Chromatographic conditions: Eclipse XDB-C 18 column (150 mm × 4.6 mm, 5 μm); potassium dihydrogen phosphate buffer (adjusted to pH 2.8 with 85% phosphoric acid) -acetonitrile (80:20) 1.0 ml · min ~ (-1), detection wavelength 200 nm, column temperature: 30 ℃. Results: Polysorbate 80 showed a good linearity (r = 0.999 2) within the range of 0.5-20 mg · ml -1. The recovery was 100.8% and the RSD was 2.8% (n = 9). Conclusion: The established HPLC method is accurate and rapid and can be used for the determination of polysorbate 80 in Compound Kushen Injection.