HPLC法测定复方赖氨酸颗粒中盐酸赖氨酸和葡萄糖酸钙的含量  

Determination of Lysine Hydrochloride and Calcium Gluconate in Compound Lysine Granules by HPLC

作　　者：李昭 郑金凤 石笑弋 刘轶 李昌亮 刘雁鸣 李晓燕 LI Zhao;ZHENG Jinfeng;SHI Xiaoyi;LIU Yi;LI Changliang;LIUYanming;LI Xiaoyan(Hunan Institute for Drug Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China;Hunan Drug Inspection Center,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001 [3]湖南省药品审核查验中心,湖南长沙410001

出　　处：《工业微生物》2023年第5期113-115,共3页Industrial Microbiology

基　　金：国家药品标准提高(食药监办药化管[2017]139号文,编号:92)。

摘　　要：文章建立了复方赖氨酸颗粒中盐酸赖氨酸和葡萄糖酸钙的HPLC检测方法。色谱柱为Welch Ultimate XB-NH2(250 mm×4.6 mm,5μm),流动相为0.05 mol/L磷酸二氢钾溶液-乙腈(40:60),流速为1.0 m L/min,柱温为30℃,进样量为10μL,检测波长为200 nm。盐酸赖氨酸在1.3460mg/m L~7.4031 mg/mL范围内与峰面积呈良好的线性关系,r=0.9999,平均回收率为99.32%,SRSD=0.27%(n=9);葡萄糖酸钙在0.0759 mg/mL~0.4175 mg/mL范围内与峰面积呈良好的线性关系,r=0.9998,平均回收率为100.51%,S_(RSD)为0.71%(n=9)。最终发现该方法简便、准确且重复性好,可用于复方赖氨酸颗粒的质量控制。A HPLC method for the determination of lysine hydrochloride and Calcium gluconate in compound lysine granules was established.The chromatographic column is Welch Ultimate XB-NH2(250 mm×4.6 mm,5μm).The mobile phase is 0.05 mol/L Monopotassium phosphate solution acetonitrile(40∶60);the flow rate is 1.0 mL/min;the column temperature is 30℃,and the injection volume is 10μL.The detection wavelength is 200 nm.Lysine hydrochloride showed a good linear relationship with peak area in the range of 1.3460 mg/mL to 7.4031 mg/mL,with r=0.9999,an average recovery rate of 99.32%,and SRSD=0.27%(n=9);Calcium gluconate showed a good linear relationship with the peak area in the range of 0.0759 mg/mL~0.4175 mg/mL,r=0.9998;the average recovery was 100.51%,and the S_(RSD )was 0.71%(n=9).It was ultimately found that this method is simple,accurate,and reproducible,and can be used for quality control of compound lysine granules.

关 键 词：复方赖氨酸颗粒 盐酸赖氨酸 葡萄糖酸钙 高效液相色谱法 含量 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]