反相高效液相色谱法测定盐酸丁卡因药膜的有关物质及含量

Determination of related substances and their contents in tetracaine hydrochloride pellicle by RP-HPLC

建立了反相高效液相色谱-紫外检测器法检测盐酸丁卡因药膜4种有关物质以及含量的方法。采用ShimadZU C18（4.6×150mm，5μm）色谱柱，甲醇溶液（含体积分数0.45％三乙胺和10mmol／L庚烷磺酸钠，60：40，V：V）为流动相，用H3PO。调节pH3.0；盐酸丁卡因在0.10～40 μg/L浓度范围内呈良好线性关系（r=0.9999）；平均回收率（n=9）为97.3％，RSD为0.68％，盐酸丁卡因和4种有关物质的检出限分别为0.1，0.01，0.005，0.01和0.02mg／L。

This paper developed a RP-HPLC - UV detector method for the determination of related substances and their contents in tetracaine hydrochloride pellicle. A Shimadzu C18, column（5 μm, 150 mm × 4.6 mm） and the mobile phase of methanol - water （ 60 ： 40, containing 0. 45% triethylamine and 10 mmol/L sodium heptanesulphonate） adjusted to pH 3.0 with phosphoric acid were adopted in this study. A good linear correlation of tetracaine hydrochloride was obtained within the range of 0.10 -40 mg/L （r = 0.9999）. The average recovery was 97.3% with a RSD of 0.68% （n = 9）. The LODs of tetracaine hydrochloride and its four related substances were 0. 1,0.01,0.005,0.01, and 0.02 mg/L, respectively. The developed method is simple, accurate and specific. It can be applied to the determination of related substances and their contents in tetracaine hydrochloride pellicle, which facilitates to the quality control for the tetracaine hydrochloride pellicle.