摘要
目的建立测定感冒疏风片中盐酸麻黄碱、盐酸伪麻黄碱、D-苦杏仁苷含量的高效液相色谱法。方法色谱柱均为Agilent Phenyl-Hexyl柱(250 mm×4.6 mm,5μm),流速均为1.0 mL/min,检测波长均为210 nm,进样量均为10μL;盐酸麻黄碱、盐酸伪麻黄碱,流动相为0.02 mol/L磷酸二氢钾水溶液(含0.2%三乙胺,磷酸调pH至3.5)-乙腈(98∶2,V/V),柱温为40℃;D-苦杏仁苷,流动相为乙腈-水(5∶95,V/V),柱温为30℃。结果盐酸麻黄碱、盐酸伪麻黄碱和D-苦杏仁苷质量浓度分别在4.166~104.15μg/mL(r=0.9999),4.210~105.250μg/mL(r=0.9999),22.40~224μg/mL(r=0.9999)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率,薄膜衣片分别为98.62%,98.40%,99.52%,RSD分别为1.45%,1.50%,1.24%(n=6);普通素片分别为99.26%,98.63%,99.63%,RSD分别为1.25%,1.12%,0.90%(n=6)。结论所建方法操作简便、结果准确,精密度、稳定性、重复性好,可用于感冒疏风片中盐酸麻黄碱、盐酸伪麻黄碱、D-苦杏仁苷的含量测定。
Objective To establish a high-performance liquid chromatography(HPLC)method for determining the contents of ephedrine hydrochloride,pseudoephedrine hydrochloride and D-amygdalin in Ganmao Shufeng Tablets.Methods The chromatographic column was Agilent Phenyl-Hexyl column(250 mm×4.6 mm,5μm),the flow rate was 1.0 mL/min,the detection wavelength was 210 nm,and the injection volume was 10μL.The mobile phase of ephedrine hydrochloride and pseudoephedrine hydrochloride was 0.02 mol/L potassium dihydrogen phosphate aqueous solution(containing 0.2%triethylamine,adjusting to pH 3.5 with phosphoric acid)-acetonitrile(98∶2,V/V),and the column temperature was 40℃;the mobile phase of D-amygdalin was acetonitrile-water(5∶95,V/V),and the column temperature was 30℃.Results The linear ranges of ephedrine hydrochloride,pseudoephedrine hydrochloride and D-amygdalin were 4.166-104.15μg/mL(r=0.9999),4.210-105.250μg/mL(r=0.9999),22.40-224μg/mL(r=0.9999)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above three components in film-coated tablets were 98.62%,98.40%,99.52%,with RSDs of 1.45%,1.50%,1.24%(n=6)respectively;those in ordinary tablets were 99.26%,98.63%,99.63%,with RSDs of 1.25%,1.12%,0.90%(n=6)respectively.Conclusion The established method is simple,accurate,precise,stable,and repeatable,which can be used for the determination of ephedrine hydrochloride,pseudoephedrine hydrochloride and D-amygdalin in Ganmao Shufeng Tablets.
作者
和祎
尹黎星
王秀丽
HE Yi;YIN Lixing;WANG Xiuli(Nujiang Lisu Autonomous Prefecture Institute for Food and Drug Control,Nujiang,Yunnan,China 673199)
出处
《中国药业》
CAS
2024年第20期91-95,共5页
China Pharmaceuticals
