摘要
建立了HPLC法测定复方氨基酸注射液(18AA-Ⅱ)中色氨酸有关物质的含量,并测定了2019年国家评价性抽验的国内7家企业155批产品。采用C_(18)色谱柱,柱温为40 ℃,以磷酸盐缓冲液∶甲醇(94∶6)为流动相A,磷酸盐缓冲液∶甲醇∶乙腈(60∶6∶34)为流动相B,梯度洗脱,流速为1.0 ml/min,检测波长为220 nm。结果显示,建立的方法准确可靠,线性关系良好,回收率满足试验要求,精密度、稳定性、专属性均良好,可有效测定复方氨基酸注射液(18AA-Ⅱ)中色氨酸有关物质的含量。
An HPLC method was established to determine the related substances of tryptophan in compound amino acid injection(18AA-Ⅱ),and 155 batches of products from 7 domestic enterprises that were sampled according to the national evaluation sampling inspection program in 2019 were analyzed in this study.The C18 column with the temperature of 40 ℃ was used.The gradient elution program comprised mobile phase A[phosphate buffer∶methanol(94∶6)]and mobile phase B[phosphate buffer∶methanol∶acetonitrile(60∶6∶34)]at a flow rate of 1.0 ml/min.And the detection wavelength was 220 nm.The results showed that this method was accurate and reliable,and had good linear relationship.The recoveries could meet the test requirements,and the precision,stability,and specificity were good,which could effectively determine the contents of tryptophan related substances in compound amino acid injection(18AA-Ⅱ).
作者
郭雷
周长明
李辉
邵天舒
GUO Lei;ZHOU Changming;LI Hui;SHAO Tianshu(Beijing Key Lab.of Analysis and Evaluation on Chinese Medicine,Beijing Institute for Drug Control,Beijing 102206)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2021年第3期390-394,共5页
Chinese Journal of Pharmaceuticals
