高效液相色谱法测定口腔溃疡药膜中盐酸丁卡因的含量

Determination of tetracaine hydrochloride in oral ulcer pellicles by HPLC

目的 建立HPLC法测定口腔溃疡药膜中盐酸丁卡因含量的方法。方法 色谱柱：Hypersil ODS2 C18（150mm×4．6mm，5μm）；流动相：甲醇-无水乙醇-水-三乙胺（70：15：15：0．05）；检测波长：310nm；流速：0．8mL·min^-1；结果 盐酸丁卡因在1．2～2．8,ug·mL内线性关系良好，r=0．9995，RSD为0．95％，平均回收率为100．20％。结论 方法简便、快速、准确，适用于口腔溃疡贴膜中盐酸丁卡因的质量控制。

OBJECTIVE To establish an HPLC method for the determination of tetracaine hydrochloride in oral ulcer pellicles. METHODS Hypersil ODS2 C18 （150mm×4.6mm, 5μm） column was used. The column tem- perature was maintained; the mobile phase consisted of methanol-absolute ethanol-water-triethylamine（70：15 ： 15： 0.05）;and the detecting wavelength was at 310nm. RESULTS The linear range of the standard curve oftetracaine hydrochloride was 1.2～2.8μg.mL^-1, R = 0.9995.The RSD was 0.95% .The recovery was 100.20% . CONCLUSIONS The method is simple, rapid and accurate. It can be used for the quality control of oral ulcer pellicles.