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

VernacularTitle:复方氨基酸注射液中有关物质N,N'-二乙酰-L-胱氨酸测定
Author: Yijuan ZHU ¹ ; Qianqian LUO ; Haishun FANG ; Biying DU ; Guanghai SU
Author Information

1. 广州市药品检验所,广州 510160
Keywords: HPLC; compound amino acid injection; N,N'-diacetyl-L-cystine; related substances
From: Drug Standards of China 2024;25(3):273-276
CountryChina
Language:Chinese
Abstract: Objective:To establish an HPLC method for the determination of N,N'-diacetyl-L-cystine in com-pound amino acid injection.Methods:The HPLC method parameters were as follows,The Atlantis dC18 column(4.6 mm × 150 mm,3 μm),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 2.697-53.94 μg·mL-1(r=0.999 9),the limits of detection and quantification were 1.4 μg·mL-1 and 4.4 μg·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.