复方氨基酸注射液中有关物质N,N′-二乙酰-L-胱氨酸测定

Determination on the test of related substance N,N′-diacetyl-L-cystine in compound amino acid injection

目的:建立测定复方氨基酸注射液中乙酰半胱氨酸有关物质N,N′-二乙酰-L-胱氨酸含量的高效液相色谱法。方法:采用Atlantis dC_(18)色谱柱(4.6 mm×150 mm,3μm),以甲酸铵溶液(取甲酸铵315 mg,加水960 mL溶解,摇匀)-乙腈-甲酸(970∶30∶1)为流动相,流速为0.7 mL·min^(-1),检测波长为210 nm。结果:N,N′-二乙酰-L-胱氨酸浓度在2.697~53.94μg·mL^(-1)范围内线性关系良好(r=0.9999),检测限和定量限分别为1.4μg·mL^(-1)和4.4μg·mL^(-1),平均回收率为100.2%,RSD为0.5%。结论:经方法学验证,证明本法适用于复方氨基酸注射液中N,N′-二乙酰-L-胱氨酸的含量测定。

Objective:To establish an HPLC method for the determination of N,N′-diacetyl-L-cystine in compound amino acid injection.Methods:The HPLC method parameters were as follows,The Atlantis dC_(18)column(4.6 mm×150 mm,3μm),The mobile phase was aammonium formate solution(315 mg ammonium formate was taken and dissolved with 960 mL water)-acetonitrile-methanoic acid(970∶30∶1)as a mobile phase,at a flow rate of 0.7 mL·min^(-1),and the detection wavelength of 210 nm.Results:The linear range of N,N′-diacetyl-L-cystine was 2.697-53.94μg·mL^(-1)(r=0.9999),the limits of detection and quantification were 1.4μg·mL^(-1)and 4.4μg·mL^(-1)respectively.The average recovery was 100.2%with RSD of 0.5%.Conclusion:The method was proved to be suitable for the determination of N,N′()-diacetyl-L-cystine in compound amino acid injection.