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目的建立环糊精手性色谱柱HPLC同时测定酒石酸布托啡诺注射液中酒石酸布托啡诺、右旋异构体和抑菌剂苄索氯铵的含量。方法采用Astec CyclobondⅡ环糊精手性色谱柱(4.6 mm×250 mm,5μm),流动相:0.05 mol·L~(-1)醋酸铵溶液(冰乙酸调节pH值为4.1)(A)-乙腈(B)梯度洗脱;检测波长:280 nm;流速:1.0 mL·min~(-1);紫外检测器。结果 3种待测组分线性关系良好,酒石酸布托啡诺线性范围为0.04~2.0 mg·mL~(-1)(r=0.999 9),平均加样回收率为100.2%;右旋异构体线性范围为0.01~2.0 mg·mL~(-1)(r=1.000),平均加样回收率为100.7%;苄索氯铵线性范围为0.02~1.0 mg·mL~(-1)(r=0.999 9),平均加样回收率为99.4%。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。
OBJECTIVE To establish a HPLC method for the simultaneous determination of butorphanol tartrate, dextral isomers and benzethonium chloride by HPLC on a cyclodextrin chiral column. Methods Astec Cyclobond Ⅱ cyclodextrin chiral column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase consisted of 0.05 mol·L -1 ammonium acetate solution (adjusted to pH 4.1 by glacial acetic acid) (A) - acetonitrile (B) gradient elution; detection wavelength: 280 nm; flow rate: 1.0 mL · min -1; UV detector. Results The linear relationship between the three tested components was good. The linear range of butorphanol tartrate was 0.04-2.0 mg · mL -1 (r = 0.999 9), the average recovery was 100.2% The linear range was 0.01-2.0 mg · mL -1 (r = 1.000) and the average recovery was 100.7%. The linear range of benzethonium chloride was 0.02-1.0 mg · mL -1 = 0.999 9), the average recovery was 99.4%. Conclusion The method is simple, accurate, reproducible and can be used for the quality control of Butorphanol tartrate injection.