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机构地区:[1]南京医科大学附属南京儿童医院药学部,江苏南京210008
出 处:《安徽医药》2016年第1期50-53,共4页Anhui Medical and Pharmaceutical Journal
摘 要:目的:建立同时测定小儿复方呋喃西林滴鼻液中盐酸麻黄碱和呋喃西林的含量测定方法。方法采用高效液相色谱法(HPLC)。色谱柱为 Agilent Eclipse Plus-C18(4.6 mm ×250 mm,5μm)色谱柱;流动相,乙腈:水相(30 mmol·L -1 Na2 HPO4,0.1%三乙胺,用50%磷酸调节 pH =3.0±0.03)=18∶82;检测波长:210 nm,375 nm;柱温:25℃;流速:0.9 mL ·min -1;进样体积:20μL。结果盐酸麻黄碱测定质量浓度在0.08~0.40 g·L -1范围内与其相应峰面积积分值呈良好线性关系(r =0.9991);精密度、稳定性、重复性试验相对标准偏差(RSD)分别为0.58%、0.67%、0.82%;平均回收率为100.56%,RSD 为1.39%(n =9)。呋喃西林测定质量浓度在0.0032~0.024g·L -1范围内与其相应峰面积积分值呈良好线性关系(r =0.9996);精密度、稳定性、重复性试验 RSD 分别为0.51%、1.32%、0.74%;平均回收率为100.68%,RSD为1.14%(n =9)。结论该方法专属性、重复性、准确性高,可用于小儿复方呋喃西林滴鼻液中盐酸麻黄碱和呋喃西林的含量测定。Objective To establish a method of quantitative determination of ephedrine hydrochloride and furacilin in Pediatric Com-pound Furacilin Nasal Drops.Methods The HPLC method was adopted with the Agilent Eclipse Plus -C18 column (4.6 mm ×250 mm,5 μm)at room temperature (25℃)and acetonitrile 0.03 mol·L -1 phosphoric acid solution (pH adjusted to 3.0 ±0.03)(18 /82)as the mobile phase at the flow rate of 0.9 mL&183;min -1 .The detection wavelength for ephedrine hydrochloride and furacilin was 210 nm and 375 nm,respectively,and the injection volume was 20 μL.Results The good linear relationship for ephedrine hydrochlo-ride was in the range of 0.08 -0.40 g&183;L -1 (r =0.999 1),while this for furacilin was in the range of 0.003 2 ~0.024 g&183;L -1 (r=0.999 6).RSDs of ephedrine hydrochloride for precision,stability and reproducibility tests were 0.58%,0.67% and 0.82%,re-spectively.The average recovery of ephedrine hydrochloride was 100.56% (RSD =1.39%,n =9).RSDs of furacilin for precision, stability and reproducibility tests were 0.51%,1.32% and 0.74%,respectively.The average recovery of furacilin was 100.68%(RSD =1.14%,n =9).Conclusions This established method was specific,accurate and reproducible for the quantitative deter-mination of ephedrine hydrochloride and furacilin in Pediatric Compound Furacilin Nasal Drops.
关 键 词:小儿复方呋喃西林滴鼻液 盐酸麻黄碱 呋喃西林 高效液相色谱法 含量测定
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