高效液相色谱法测定氨甲苯酸注射液的含量及有关物质  

Determination of aminomethylbenzoic acid injection and related substances by HPLC

作　　者：朱迎军 兰文 王伟娇 

机构地区：[1]湖南省食品药品检验研究院,长沙410001

出　　处：《中南药学》2012年第4期263-265,共3页Central South Pharmacy

摘　　要：目的采用HPLC法测定氨甲苯酸注射液的含量及有关物质。方法色谱柱:氨基键合硅胶柱(BostonGreen Amino-NH2,4.6mm×250mm,5μm);流动相:乙腈-0.04%醋酸钠溶液(氢氧化钠调pH至7.4)(70∶30);检测波长:230nm;流速:1.0mL.min-1;进样量:10μL;柱温:30℃。结果在该色谱条件下,氨甲苯酸注射液在0.03～0.4mg.mL-1具有良好的线性关系(r=1);平均回收率为99.9%,RSD为0.05%(n=9)。结论本法简便、快速、准确,专属性好,为氨甲苯酸注射液含量及有关物质质量标准的修订提供了依据。Objective To establish an HPLC method to determine the content of aminomethylbenzoic acid and related substances. Methods The separation was performed on Boston Green Amino NHz （4.6 mm× 250 mm, 5μm） . The mobile phase was composed of acetonitrile-0.04% sodium acetate aqueous （pH being adjusted to 7.4 with NaOH） （70 ： 30） . The flow rate was 1.0 mL . min -1. The detection wavelength was 230 nm. The chromatography was con ducted at 30℃. Restults The linear range of atorvastatin was 0.03-0.4 mg . mL-1 （r= 1） . The average recovery was 99.9 % and the RSD was 0.05%. Conclusion The method is simple, quick and accurate, which is suitable for the determination of aminomethylbenzoic acid and related substances in aminomethylbenzoic acid injection.

关 键 词：氨甲苯酸注射液 高效液相色谱法 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]