高效液相色谱法测定盐酸利多卡因贴剂含量

Measurement of lidocaine hydrochloride in patch by HPLC

文中建立了盐酸利多卡因贴剂含量的测定方法。用Waters公司Xterra C18柱 (5 μm ,3 9mm× 15 0mm) ,流动相为甲醇 0 0 5mol·L-1的碳酸氢铵水溶液 (用氨水调节pH =8 5 0 ,体积比为 5 0∶5 0 ) ,流速 1 0mL·min-1。结果显示盐酸利多卡因在 2 0～ 6 4 0mg·L-1范围内呈现良好的线性关系 ,r值为 0 9998。利多卡因回收率为99 77% ,RSD为 0 6 8%。本方法简单、灵敏、准确 ,可作为该制剂内在质量的控制方法。

A high performance liquid chromatography(HPLC) method for the measurement of lidocaine hydrochloride in patch was developed. It was performed by using XterraC 18 column (5μm, 3.9mm×150mm). The mobile phase, consisting of methanol -0.05mol·L -1 ammonium hydrogen carbonate solution (50∶50, v/v) adjusted to pH=8.50 with ammonia solution, was maintained to a flow-rate of 1.0mL·min -1 . The calibration curve had a good linearity in the range of 20～640mg·L -1 . The average recovery was 99.77% and RSD was 0.68%. This method was simple, sensitive and accurate. It can be used for the quality control of the patch.