高效液相色谱法测定复方氨基酸注射液(9AA)中抗氧剂的含量

高效液相色谱法测定复方氨基酸注射液(9AA)中抗氧剂的含量阚微娜;王沪凯
【期刊名称】《中国生化药物杂志》
【年(卷),期】2012(33)6
【摘要】目的建立高效液相色谱(HPLC)测定复方氨基酸注射液(9AA)中抗氧剂焦亚硫酸钠与L-盐酸半胱氨酸含量的方法.方法采用HPLC法测定.强酸型阳离子交换柱(磺化苯乙烯-二乙烯基苯共聚物),以0.04 mol/L磷酸溶液为流动相,柱温为50℃,检测波长为200 nm,测定焦亚硫酸钠的含量;采用C18柱,以二硫代二丙酸为氧化剂,异硫氰酸苯酯柱前衍生化,梯度洗脱,检测波长为254 nm,测定L-盐酸半胱氨酸的含量.结果焦亚硫酸钠和L-盐酸半胱氨酸分别在0.04～0.36和4.24～38.12 mg/L范围内线性关系良好,回收率分别为98.6％和99.6％,RSD分别为
0.90％和1.5％(n=9).结论建立了准确高效的焦亚硫酸钠与L-盐酸半胱氨酸的HPLC测定方法,为质量标准的提高提供依据.%Purpose To establish HPLC methods for the determination of antioxidant sodium pyrosulfite and L-cysteine hydrochloride monohydrate in Compound Amino Acids Injections (9AA). Methods The MKF-CIS chromatograph column was used with the mobile phase of 0. 04 mol/L H3PO4. The detection wavelength was 200 nm to determine the content of the sodium pyrosulfite. A C18 column was used for HPLC method with PITC precolumn derivation, DTDPA as oxidant agent and determing L-cysteine hydro-chloride monohydrate at 254 nm. Results The calibration curves of the two components were 0. 04-0. 36
mg/mL( sodium pyrosulfite) and 4.24-38. 12 mg/L( cysteine) respectively.
Their recoveries were 98. 6% and 99. 6% , with RSD of 0. 90% and 1. 5% (n = 9) , respectively. Conclusion The methods can accurately and efficiently determine sodium pyrosulfite and cysteine so as to improve the quality of injection.
【总页数】4页(P833-836)
【作者】阚微娜;王沪凯
【作者单位】辽宁省食品药品检验所,辽宁沈阳110023;沈阳市第七人民医院,辽宁沈阳110003
【正文语种】中文
【中图分类】R927.1
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