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
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篇名: 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
TITLE:
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20 μL。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26~411 μg/mL(r=0.999 6)、16~254 μg/mL(r=0.999 8)、16~748 μg/mL(r=0.998 1)、35~565 μg/mL(r=0.999 8)、25~404 μg/mL(r=0.999 7);定量限分别为3.6、3.1、4.0、9.6、6.3 μg/mL,检测限分别为1.9、1.3、1.4、2.9、2.3 μg/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。
ABSTRACT: 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 20 μL. RESULTS: The linear ranges of acetaminophen,salicylamide,acetylsalicylic acid,chlorphenamine maleate,triprolidine hydrochloride were 26-411 μg/mL(r=0.999 6), 16-254        μg/mL(r=0.999 8), 16-748 μg/mL(r=0.998 1), 35-565 μg/mL(r=0.999 8) and 25-404 μg/mL(r=0.999 7),respectively. LOQ were 3.6, 3.1, 4.0, 9.6, 6.3 μg/mL; LOD were 1.9, 1.3, 1.4, 2.9, 2.3 μg/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.
期刊: 2018年第29卷第20期
作者: 李欣,顾王文,李金丰,张志文,孙考祥
AUTHORS: LI Xin,GU Wangwen,LI Jinfeng,ZHANG Zhiwen,SUN Kaoxiang
关键字: 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
KEYWORDS: Auto·Blend Plus method; ACQUITY Arc system; HPLC; Acetaminophen; Salicylamide; Acetylsalicylic acid; Chlorphenamine maleate; Triprolidine hydrochloride; Content determination
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