高效液相色谱法测定氨酪酸氯化钠注射液中的α-吡咯烷酮

目的建立高效液相色谱法检测氨酪酸氯化钠注射液中α-吡咯烷酮含量的方法标准。方法选用CAPCELL PAK C18柱为色谱柱;流动相采用p H2.1的磷酸二氢钾溶液-甲醇（90：10）;流速维持在1.0m L/min;紫外检测波长设定为210nm;柱温为30℃;进样量为10μL。结果α-吡咯烷酮浓度为0.4-5.0mg/L时其线性关系良好,r=0.9998,平均回收率为100.27%（RSD=0.54%,n=6）。结论本研究建立的HPLC法对于氨酪酸氯化钠注射液中的α-吡咯烷酮测定效果良好且方便快捷。

Determination of aminobutyric acid in aminobutyric acid sodium chloride injection by HPLC

Objective To establish an HPLC standard method to assay the α-pyrrolidone content in aminobutyric acid sodium chloride injection. Methods A CAPCELL PAK C18 column was adopted,and potassium dihydrogen phosphate solution were diluted with water to 1000 m L as mobile phase,which adjusted to p H 2.1 with phosphoric acid）-methanol（90：10,v/v）.The flow rate was 1.0m L/min,the detection wavelength was 210 nm and column temperature was 30℃.Results The linear correlation of aminobutyric acid was fine within 0.4-5.0mg/L（r=0.9998）. The average recovery was 100.27%（RSD=0.54%,n=6）. Conclusion The HPLC method we established was good and convenient to determine the aminobutyric acid contents in amino butyric acid sodium chloride injection.