基于Auto·Blend Plus技术的HPLC法同时测定抗感冒复方制剂中5种不同酸碱性成分的含量  

Simultaneous Determination of 5 Kinds of Acid and Alkaline Components in Anti-cold Compound Preparation by HPLC Based on Auto·Blend Plus Technology

作　　者：李欣 顾王文 李金丰 张志文 孙考祥[1] LI Xin;GU Wangwen;LI Jinfeng;ZHANG Zhiwen;SUN Kaoxiang(School of Pharmacy,Yantai University,Shandong Yantai 264005,China;Center for Formulation Research,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai 201203,China)

机构地区：[1]烟台大学药学院,山东烟台264005 [2]中国科学院上海药物研究所药物制剂研究中心,上海201203

出　　处：《中国药房》2018年第20期2758-2762,共5页China Pharmacy

基　　金：国家科技计划课题(No.2015CB932103)

摘　　要：目的:建立同时测定抗感冒复方制剂中5种不同酸碱性成分含量的方法。方法:采用高效液相色谱法,工作站为ACQUITY Arc系统的Auto·Blend Plus软件,色谱柱为Discovery~?HS F5-5,流动相为酸混合液-碱混合液-甲醇-0.3%三乙胺(梯度洗脱),流速为1.0 mL/min,检测波长为270 nm(对乙酰氨基酚、水杨酰胺、马来酸氯苯那敏、盐酸曲普利啶)、299 nm(乙酰水杨酸),柱温为35℃,进样量为20μL。结果:对乙酰氨基酚、水杨酰胺、乙酰水杨酸、马来酸氯苯那敏、盐酸曲普利啶检测质量浓度线性范围分别为26～411μg/mL(r=0.999 6)、16～254μg/mL(r=0.999 8)、16～748μg/mL(r=0.998 1)、35～565μg/mL(r=0.999 8)、25～404μg/mL(r=0.999 7);定量限分别为3.6、3.1、4.0、9.6、6.3μg/m L,检测限分别为1.9、1.3、1.4、2.9、2.3μg/mL;中间精密度、稳定性、重复性试验的RSD均小于2%;加样回收率分别为100.0%～102.0%(RSD=0.59%,n=9)、95.2%～101.0%(RSD=1.55%,n=9)、96.2%～99.9%(RSD=1.24%,n=9)、96.2%～101.5%(RSD=1.57%,n=9)、96.3%～98.9%(RSD=0.83%,n=9);耐用性试验的RSD均小于3%。结论:该方法操作简便、准确,精密度、稳定性、重复性、耐用性好,可用于抗感冒复方制剂中5种不同酸碱性成分含量的同时测定。OBJECTIVE:To establish the method for simultaneous contents determination of 5 kinds of acid and alkaline componentsin anti-cold compound preparation.METHODS:HPLC method was adopted.The workstation was Auto·Blend Plus software of ACQUITY Arc system.The determination was performed on Discovery?HS F5-5 column with mobile phase consisted of acid mixture-base mixture-methanol-0.3%triethylamine(gradient elution)at the flow rate of 1.0 mL/min.The detection wavelengths were set at 270 nm(acetaminophen,salicylamide,chlorphenamine maleate,triprolidine hydrochloride)and 299 nm(aspirin).The column temperature was 35℃,the sample size was 20μL.RESULTS:The linear ranges of acetaminophen,salicylamide,acetylsalicylic acid,chlorphenamine maleate,triprolidine hydrochloride were 26-411μg/mL(r=0.999 6),16-254μg/mL(r=0.999 8),16-748μg/mL(r=0.998 1),35-565μg/mL(r=0.999 8)and 25-404μg/mL(r=0.999 7),respectively.LOQ were 3.6,3.1,4.0,9.6,6.3μg/mL;LOD were 1.9,1.3,1.4,2.9,2.3μg/mL,respectively.RSDs of intermediate precision,stability and reproducibility tests were all lower than 2%.Average recoveries were 100.0%-102.0%(RSD=0.59%,n=9),95.2%-101.0%(RSD=1.55%,n=9),96.2%-99.9%(RSD=1.24%,n=9),96.2%-101.5%(RSD=1.57%,n=9),96.3%-98.9%(RSD=0.83%,n=9),respectively.RSDs of durability tests were lower than 3%.CONCLUSIONS:The method is simple,accurate,precise,stable,reproducible and durable,and can be used for simultaneous contents determination of 5 kinds of acid and alkaline components in anti-cold compound preparation.

关 键 词：Auto·Blend Plus技术 ACQUITY Arc系统 高效液相色谱法 对乙酰氨基酚 水杨酰胺 乙酰水杨酸 马来酸氯苯那敏 盐酸曲普利啶 含量测定 

分 类 号：R927.2[医药卫生—药学]