高效液相色谱法测定多烯磷脂酰胆碱注射液中苯甲醇含量

Determination of Benzyl Alcohol in Polyene Phosphatidylcholine Injection with HPLC

目的建立多烯磷脂酰胆碱注射液中苯甲醇的含量测定方法。方法采用高效液相色谱法,以十八烷基硅烷键合硅胶为色谱柱,甲醇-水(48∶52)为流动相,检测波长254nm,流速1.0mL/min。结果苯甲醇质量浓度在0.1～2.0mg/mL范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为99.76%,RSD=0.52%(n=6)。结论该方法简便、准确,灵敏度高,适用于多烯磷脂酰胆碱注射液中苯甲醇的含量测定。

Objective To establish a method for determination of benzyl alcohol in polyene phosphatidylcholine injection. Methods HPLC method was adopted. The column was Agilent ZORBAX SB- C18 （250 mm×4. 6 mm,5 μm）, and the mobile phase was methanol- water （48： 52）. The detection wavelength was 254 nm. The flow rate was 1.0 mL/min. Results The linear range of benzyl alcohol was 0. 1 - 2.0 mg/mL, r = 0. 999 9, the average recovery rate was 99.76%, RSD = 0. 52% （ n = 6）. Conclusion This method is simple, accurate, sensitive and suitable for the determination of benzyl alcohol in polyene phosphatidylcholine injection.