复方氨基酸注射液中有关物质N,N'-二乙酰-L-胱氨酸测定

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中文摘要：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 dC18色谱柱(4。6 mm × 150 mm，3 µm)，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。94 µg·mL-1范围内线性关系良好(r=0。999 9)，检测限和定量限分别为1。4 μg·mL-1和4。4 μg·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A，N'-二乙酰-L-胱氨酸的含量测定。

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

外文摘要：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.

外文关键词：

HPLCcompound amino acid injectionN,N'-diacetyl-L-cystinerelated substances

作者：

祝艺娟、罗倩倩、方海顺、杜碧莹、苏广海

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作者单位：

广州市药品检验所,广州 510160

关键词：

高效液相色谱法复方氨基酸注射液 N,N'-二乙酰-L-胱氨酸有关物质

出版年：

2024

DOI：