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  

Determination of α-pyrolidone in aminobutyric acid sodium chloride injection by HPLC

作　　者：刘艳[1] 徐玉文 李玉梅 

机构地区：[1]山东省淄博市妇幼保健院,山东淄博255029 [2]山东省药品检验所,山东济南250101 [3]山东博士伦福瑞达制药有限公司,山东济南250101

出　　处：《中国生化药物杂志》2012年第4期422-424,共3页Chinese Journal of Biochemical Pharmaceutics

基　　金：国家药典委员会资助[国药典化发[2010]84号文]

摘　　要：目的建立测定氨酪酸氯化钠注射液中α-吡咯烷酮含量的高效液相色谱法。方法采用CAPCELLPAK C18柱,以磷酸二氢钾溶液(磷酸二氢钾10.0 g与己烷磺酸钠1.1 g,加水溶解并稀释至1 000 mL,用磷酸调pH值至2.1)-甲醇(90∶10)为流动相;流速:1.0 mL/min,检测波长:210 nm,柱温:30℃,进样量:10μL。结果α-吡咯烷酮在0.4～4.8 mg/L范围内线性关系良好(r=1.000),平均回收率为100.9%(RSD=1.39%,n=9)。结论建立的方法准确、简便、快速,适用于氨酪酸氯化钠注射液中α-吡咯烷酮的含量测定。Purpose To establish a HPLC method for the determination of α-pyrolidone in aminobutyric acid sodium chloride injection.Methods The components were separated by a CAPCELL PAK C18 column（250 mm×4.6 mm,5 μm）and the mixture of potassium dihydrogen phosphate solution（dilute potassium dihydrogen phosphate sodium 10.0 g and hexanesulfonate 1.1 g with water to 1 000 mL and adjust pH 2.1 with phosphoric acid）-methanol（90∶ 10）as the mobile phase,and detected with the UV detector at 210 nm.The flow rate was 1.0 mL/min.The temperature of the column was 35 ℃.Results The linear correlation of α-pyrolidone was fine within 0.4-4.8 mg/L.The average recovery was 100.9%（RSD=1.39%,n=9）.Conclusion This method was accurate,simple,quick and effective for testing α-pyrolidone in aminobutyric acid sodium chloride injection.

关 键 词：氨酪酸氯化钠注射液 Α-吡咯烷酮 含量测定 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]