摘要
目的建立氨酪酸氯化钠注射液中α-吡咯烷酮含量的HPLC测定方法。方法按如下方法设定色谱条件。色谱柱：CAPCELL PAK C18柱;流动相：磷酸二氢钾溶液-甲醇（90∶10）;磷酸二氢钾溶液的配制：将10.0g磷酸二氢钾、1.1g己烷磺酸钠加水溶解并稀释至1000m L,然后用磷酸调节溶液p H值到2.1;流速：1.0m L/min;检测波长：210nm;进样量：10μL;柱温：30℃。结果α-吡咯烷酮的含量在0.4-4.9μg/m L范围内时,线性关系好,r=0.9997,平均回收率达99.97%（RSD=0.48%,n=10）。结论 HPLC法用于氨酪酸氯化钠注射液中的α-吡咯烷酮含量测定,操作简单、便捷,结果准确。
Objective To establish a HPLC method for the content of α-pyrolidone in aminobu-tyric acid sodium chloride injection. Methods Set chromatographic conditions as follows. Chromatographic column： CAPCELL PAK C18 column; Mobile phase： potassium dihydrogen phosphate solution- methanol（90 ∶ 10）; the preparation of the potassium dihydrogen phosphate solution： potassium dihydrogen phosphate 10.0 g and 10.0 g hexane sulfonic acid sodium is dissolved with water and diluted to 1000 m L, then adjustment the p H of the solution with phosphoric acid to 2.1; Flow rate： 1.0 m L/min; Detection wavelength ： 210 nm; Sample quantity： 10 μL; Column temperature： 30℃. Results The content of α-pyrolidon within the scope of 0.4 to 4.9 μg/L, good linear relation, r=0.9997, the average recovery is 99.97%（RSD=0.48%, n=10）. Conclusion The HPLC method should be used in the determination of α-pyrolidone＇s content in aminobu-tyric acid sodium chloride injection, the operation is simple and convenient and the result is accurate.
出处
《中国医药科学》
2015年第16期48-50,共3页
China Medicine And Pharmacy
