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高效液相色谱法同时测定感冒疏风片中3种成分含量

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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,5 μm),流速均为 1。0 mL/min,检测波长均为 210 nm,进样量均为 10 μL;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。15 μg/mL(r=0。999 9),4。210~105。250 μg/mL(r=0。999 9),22。40~224 μg/mL(r=0。999 9)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。
Simultaneous Determination of Three Components in Ganmao Shufeng Tablets by HPLC
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,5 μm),the flow rate was 1.0 mL/min,the detection wavelength was 210 nm,and the injection volume was 10 μL.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 4.166-104.15 μg/mL(r=0.999 9),4.210-105.250 μg/mL(r=0.999 9),22.40-224 μg/mL(r=0.999 9)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.

HPLCephedrine hydrochloridepseudoephedrine hydrochlorideGanmao Shufeng TabletsD-amygdalin

和祎、尹黎星、王秀丽

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云南省怒江傈僳族自治州食品药品检验所,云南 怒江 673199

高效液相色谱法 盐酸麻黄碱 盐酸伪麻黄碱 感冒疏风片 D-苦杏仁苷

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(20)