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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(4.6×150 mm,5μm)色谱柱,甲醇溶液(含体积分数0.45%三乙胺和10 mmol/L庚烷磺酸钠,60∶40,V:V)为流动相,用H3PO4调节pH 3.0;盐酸丁卡因在0.10~40μg/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0.02 mg/L。
A method was developed for the determination of four related substances and contents of tetracaine hydrochloride film by reversed-phase high performance liquid chromatography-ultraviolet detector. The mobile phase was a Shimadzu C18 column (4.6 × 150 mm, 5 μm), methanol (containing 0.45% triethylamine and 10 mmol / L sodium heptanesulfonate, 60:40 V: V) (R = 0.9999). The average recovery (n = 9) was 97.3% and the RSD was 0.68%. The concentration of tetracaine hydrochloride and 4 The detection limits of the related substances were 0.1, 0.01, 0.005, 0.01 and 0.02 mg / L, respectively.