HPLC法测定多维铁口服溶液中盐酸赖氨酸的含量  

Determination of lysine hydrochloride in multivitamin iron oral solution by HPLC

作　　者：陈静[1] CHEN Jing(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所

出　　处：《中国药品标准》2019年第5期400-403,共4页Drug Standards of China

摘　　要：目的:建立HPLC法测定多维铁口服溶液中盐酸赖氨酸的含量。方法:采用2,4-二硝基氟苯为衍生化试剂,使盐酸赖氨酸衍生化。采用Gemini C18柱(4.6 mm×250 mm,5μm);以0.05 mol L^-1醋酸钠溶液(用冰醋酸调pH至6.4)-甲醇(45∶55)为流动相,检测波长为354 nm。结果:盐酸赖氨酸在1.076~21.52μg mL^-1浓度范围内线性关系良好,平均加样回收率为99.1%(RSD=0.6%,n=9)。4个厂家样品(共12批)中盐酸赖氨酸的标示百分含量分别为91.0%~92.2%、81.5%~84.3%、101.9%~103.1%、98.9%~100.2%。结论:本法简便准确,稳定性好,可用于测定多维铁口服溶液中盐酸赖氨酸的含量。Objective:An HPLC method was established for the determination of lysine hydrochloride in multivitamin iron oral solution.Methods:The lysine hydrochloride was treated with 2,4-dinitrofluorobenzene,derivatized lysine hydrochloride was separated on a Gemini C18 column(4.6 mm×250 mm,5μm)with the mobile phase of 0.05 mol L^-1 sodium acetate solution(adjust pH to 6.4 by acetic acid)-methanol(45∶55),and the detection wavelength was 354 nm.Results:The linear range of Lysine Hydrochloride fell into 1.076-21.52μg mL^-1 with the average recovery of 99.1%(RSD=0.6%,n=9).The contents of lysine hydrochloride in the samples of 4 enterprises(12 batchs)were 91.0%-92.2%,81.5%-84.3%,101.9%-103.1%and 98.9%-100.2%respectively.Conclusion:The method is simple,accurate and stable,which can be used for the determination of lysine hydrochloride in multivitamin iron oral solution.

关 键 词：多维铁口服溶液 盐酸赖氨酸 HPLC法 含量测定 

分 类 号：R291.2[医药卫生—民族医学]