摘要
目的建立测定小儿复方氨基酸注射液中盐酸半胱氨酸含量的反相液相色谱法。方法采用菲罗门Gemini C18(5μm,4.6 mm×250 mm)色谱柱;以缓冲液(取硫酸铵5.0 g和庚烷磺酸钠4.0 g加水1 000 mL溶解,用HCl调节pH 1.5)为流动相A,甲醇为流动相B,梯度洗脱;流速:1.0 mL/min;检测波长:205 nm:柱温:40℃;进样量:10μL。结果盐酸半胱氨酸在0.021 04～0.841 6 mg/mL范围内,呈良好的线性关系(r=1.000 0);平均回收率(n=15)为98.4%,RSD为1.8%; 18AA-Ⅰ注射液中盐酸半胱氨酸的含量普遍高于18AA-Ⅱ和19AA-Ⅰ注射液。结论建立的方法专属性高,结果准确可靠,可用于小儿复方氨基酸注射液中盐酸半胱氨酸含量的控制,18AA-Ⅱ和19AA-Ⅰ注射液生产工艺有待改进。
Objective To establish an HPLC method for determination of cysteine hydrochloride in pediatric compound amino acid injection.Methods The samples were separated on a Gemini C18column(5μm,250mm×4.6mm)by gradient elution at a flow rate of1.0mL/min.The mobile phase A was buffer consisted of5.0g ammonium sulfate and4.0g sodium heptanesulfonate in1000mL water(adjusting pH1.5with hydrochloric acid),the mobile phase B was Methanol.The detection wavelength was205nm,the column temperature was40℃.Results Cysteine hydrochloride exhibited good linearity in the range of0.02104-0.8416mg/mL(r=1.0000).The average recovery(n=3)of Cysteine hydrochloride was98.4%,RSD%(n=9)was1.8.The content of Cysteine hydrochloride in18AA-Ⅰinjection was generally higher than that in18AA-Ⅱ和19AA-Ⅰinjection.Conclusions The established method is specific,accurate and sensitive,which is suitable for the determination of cysteine hydrochloride in pediatric compound amino acid injection.The production process of18AA-Ⅱ和19AA-Ⅰinjection needs to be improved.
作者
郭志渊
朱恒怡
赵欣庆
谢华
GUO Zhiyuan;ZHU Henyi;ZHAO Xinqin;XIE Hua(Sichuan Institute for Food and Drug Control,Chengdu 611731,China)
出处
《广东药科大学学报》
CAS
2018年第6期700-703,共4页
Journal of Guangdong Pharmaceutical University
