摘要
目的建立高效液相色谱法测定感丹(氨酚伪麻那敏泡腾颗粒)中马来酸氯苯那敏、对乙酰氨基酚、盐酸伪麻黄碱的含量及马来酸氯苯那敏含量均匀度。方法采用Agela Venusil XBP-C_(18)柱(4.6mm×250mm,5μm),流动相为甲醇-0.05mol.L^(-1)磷酸二氢钾溶液(10%磷酸调pH至3.0)(25:75),流速为1.0mL.min^(-1),检测波长为210nm,进样量10μL,柱温为35℃。结果马来酸氯苯那敏浓度在0.16~0.56μg.mL^(-1)之间、对乙酰氨基酚浓度在2.0~7.0μg.mL^(-1)之间、盐酸伪麻黄碱浓度在0.24~0.84μg.mL^(-1)之间均与峰面积呈良好线性关系,r=0.999 0~0.999 8;平均加样回收率分别为101.62%(RSD=1.26%)、97.04%(RSD=0.98%)、95.02%(RSD=2.18%)。结论本法操作简便,结果准确,可作为该制剂的质量控制方法。
Objective This study aimed to establish HPLC method to determinate the concentration of three components of Gandan（Compound Paracetamd Effervescent Granules）,including chlorpheniramine maleate,acetaminophen,and pseudoephedrine hydrochloride;and to determinate content uniformity of chlorphenamine maleate.Methods The Agela Venusil XBP-C18column（4.6 mm×250 mm,5 μm）was used,of which mobile phase of methanol -0.05 mol.L^-1 potassium dihydrogen phosphate solution（pH 3.0,adjusted by 10% phosphoric acid）25：75）,flow rate of 1.0 mL.min^-1,detection wavelength of 210 nm,sample quantity of 10 μl,column temperature of 35 ℃.Results The concentration of chlorpheniramine maleate was 0.16～0.56 μg. mL^-1,the concentration of acetaminophen was 2.0～7.0 μg. mL^-1,the concentration of pseudoephedrine hydrochloride was 0.24～0.84 μg. mL^-1,and they all had good linear relationship with the peak area,r=0.999 0～0.9998;The average sample recovery rate was101.62%（RSD = 1.26%）,97.04%（RSD = 0.98%）,0.98%（RSD = 2.18%）.Conclusion This method is simple,accurate,and can provide a reference for quality control of the preparations.
作者
杨立勇
徐立
Yang Liyong Xu Li(Qujing Center for Food and Drug Control, Qujing 655000, China Division of Educational Assessment, Dali University, Dali 671000, China)
出处
《四川解剖学杂志》
2017年第2期12-15,共4页
Sichuan Journal of Anatomy
