HPLC法同时测定酒石酸布托啡诺注射液中酒石酸布托啡诺和苄索氯铵的含量

目的: 建立反相高效液相色谱法同时测定酒石酸布托啡诺注射液中酒石酸布托啡诺和抑菌剂苄索氯铵的含量。 方法: 采用GC Sciences Phenyl 苯基色谱柱(250 mm×4.6 mm,5 μm),以0.05 mol·L^-1醋酸铵溶液(用冰醋酸调节pH为4.1)-乙腈为流动相进行梯度洗脱[0~15 min,A-B(70:30);15~25 min,A-B(70: 30)→A-B(30: 70);25~35 min,A-B(30: 70);35~36 min,A-B(30: 70)→A-B(70: 30);36~45 min,A-B(70: 30)],流速1.0 mL·min^-1,检测波长280 nm,柱温30 ℃。 结果: 酒石酸布托啡诺浓度在0.04~2.18 mg·mL^-1范围内与峰面积呈良好的线性关系(r=1.000),平均加样回收率为99.8%;苄索氯铵浓度在0.02~1.08 mg·mL^-1范围内与峰面积呈良好的线性关系(r=0.9999),平均加样回收率为99.1%。 结论: 该方法简便、准确,重复性好,可用于酒石酸布托啡诺注射液的质量控制和质量标准提高。

Objective: To establish an HPLC method for the simultaneous determination of butophanol edetate and benzethonium chloride which works as the bacteriostatic agent in butophanol tartrate injection. Methods: The HPLC analysis was performed on a GC Sciences Phenyl column(250 mm×4.6 mm,5 μm),with mobile phase of 0.05 mol·L^-1 ammonium acetate solution (the pH value was adjusted to 4.1 by acetic acid) and acetonitrile using gradient elution[0-15 min,A-B(70:30);15-25 min,A-B(70: 30)→A-B(30: 70);25-35 min,A-B(30: 70);35~36 min,A-B(30: 70)→A-B(70: 30);36-45 min,A-B(70: 30)]at a flow rate of 1.0 mL·min^-1,the detection wavelength was 280 nm,and the column temperature was 30 ℃. Results: Butophanol edetate curves were linear in the range of 0.04-2.18 mg·mL^-1(r=1.000),and the average recovery was 99.8%.Benzethonium chloride curves were linear in the range of 0.02-1.08 mg·mL^-1(r=0.9999),and the average recovery was 99.1%. Conclusion: The method is simple,accurate and reproducible.It can be used for quality control and improvement of the quality standard for butophanol tartrate injection.

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