高效液相色谱法测定盐酸普鲁卡因溶液中盐酸普鲁卡因的含量

Content Determination of Procaine Hydrochloride in Procaine Hydrochloride Solution by HPLC

目的建立高效液相色谱法（HPLC）测定盐酸普鲁卡因溶液中盐酸普鲁卡因的含量。方法色谱柱为Agilent Eclipse XDB-C_（18）（4.6 mm×150 mm,5μm）;流动相为0.1%庚烷磺酸钠0.05 mol/L磷酸二氢钾溶液（磷酸调节p H值至3.0）-甲醇（68∶32）,流速为1.0 ml/min;检测波长为290 nm;柱温为25℃;进样量为10μl;运行时间为6 min。结果盐酸普鲁卡因在1.002~20.04μg/ml范围内与其峰面积线性关系良好（r=0.9 999）,平均回收率为98.41%,相对标准偏差为1.52%。结论 HPLC测定结果准确、重复性好,可用于盐酸普鲁卡因溶液的质量评价。

Objective To establish the high performance liquid chromatography（ HPLC） method to detect Procaine Hydrochloride content in Procaine Hydrochloride solution. Methods The chromatographic column was Agilent Eclipse XDB-C_（18）（ 4. 6 mm × 150 mm,5 μm）; the mobile phase consisted of 0. 1% sodium heptanesulfonate in0. 05 mol/l monopotassium phosphate solution（ regulated PH value of phosphoric acid up to 3. 0） and methanol（ 68∶ 32）; the flow rate was 1. 0 ml/min; the detection wavelength was set at 290 nm; the column temperature was25℃,and the injection volume was 10 μl with 6 min running time. Results A good linear correlation between Procaine Hydrochloride and its peak area was observed within the range of 1. 002- 20. 04 μg/ml（ r = 0. 9 999）. The average recovery was 98. 41%（ n = 9） with 1. 52% relative standard deviation（ RSD）. Conclusion The HPLC method is accurate with good repeatability,and therefore it is suitable for evaluating the quality of Procaine Hydrochloride solution.