高效液相色谱法测定盐酸丁卡因注射液中盐酸丁卡因的含量及有关物质

摘要

目的：建立高效液相色谱法测定盐酸丁卡因注射液中盐酸丁卡因含量及有关物质检查的方法。方法采用高效液相色谱法，色谱柱为 Agilent ZORBAX SB-C18柱（250 mm ×4．6 mm，5μm），流动相 A 和 B 为0．05 mol·L －1磷酸二氢钾溶液[用稀磷酸或三乙胺调节 pH 值至（3．0±0．1）]和甲醇（70∶30），梯度洗脱，流速为1．0 mL·min －1，柱温30°C，盐酸丁卡因含量测定检测波长310 nm，有关物质检测波长为280 nm，进样量为20μL。结果盐酸丁卡因在10．0～100．0 mg·L －1范围内线性良好（r ＝0．9999），平均回收率为98．73％，RSD 值为0．72％（n ＝9）。结论该方法精密度高、准确可靠，可用于盐酸丁卡因注射液质量控制。%Objective To establish an HPLC method for determining the content of tetracaine hydrochloride and the related substances in Tetracaine Hydrochloride Injection.Methods HPLC was used.The analytical column was Agilent ZORBAX SB-C18 (5 μm,4.6 × 250 mm),0.05 mol·L -1 potassium dihydrogen phosphate solution[adjusted with phosphoric acid or triethylanune to pH(3.0 ±0.1)] and methanol(70∶30)were adopted as mobile phase using gradient elution with the flow rate of 1.0 mL·min -1 .The detection wave-length was 310 nm for tetracaine hydrochloride,and 280 nm for the related substances.The column temperature was 30°C and the injec-tion volume was 20 μL.Results The good linear relationship of tetracaine hydrochloride ranged from 10.0 to 100.0 mg·L -1 (r =0.999 9),and the average recovery was 98.73% with theRSD of 0.72%(n =9).Conclusions The method is reliable,accurate and can be used for the quality control of Tetracaine Hydrochloride Injection.