高效液相色谱法测定胃痛宁片中天仙子浸膏含量  

Content Determination of Hyoscyamus Niger Extract in Weitongning Tablets by HPLC

作　　者：马丽 杨甲忠 孟珊 张征 杨爽 MA Li;YANG Jiazhong;MENG Shan;ZHANG Zheng;YANG Shuang(Chengde Institute for Food and Drug Control,Chengde,Hebei,China 067101;Hebei Institute for Drug Control,Shijiazhuang,Hebei,China 050011)

机构地区：[1]河北省承德市食品药品检验检测中心,河北承德06711 [2]河北省药品检验研究院,河北石家庄050011

出　　处：《中国药业》2020年第5期105-107,共3页China Pharmaceuticals

摘　　要：目的建立测定胃痛宁片中天仙子浸膏含量的高效液相色谱(HPLC)法。方法色谱柱为SunFire C18柱(250 mm×4.6 mm,5μm),流动相为乙腈(A)-0.1%磷酸溶液(B,含0.02%的三乙胺),梯度洗脱,流速为1.0 m L/min,柱温为35℃,检测波长为210 nm。结果氢溴酸东莨菪碱和硫酸阿托品与相邻杂质峰均可以完全分离;氢溴酸东莨菪碱和硫酸阿托品质量浓度分别在0.002146~0.10729 mg/m L和0.002071~0.10354 mg/m L范围内与峰面积线性关系良好,平均回收率分别为100.04%和98.91%,RSD分别为5.86%和5.54%(n=9)。结论该法可有效测定胃痛宁片中天仙子浸膏的含量,可为完善胃痛宁片质量标准提供参考。Objective To establish a high performance liquid chromatography(HPLC)method for the determination of Hyoscyamus Niger Extract in Weitongning Tablets.Methods SunFire C18 column(250 mm×4.6 mm,5μm)was used;mobile phase A was acetonitrile,mobile phase B was 0.1%phosphoric acid solution(containing 0.02%triethylamine),gradient elution;the flow rate was 1.0 mL/min,the column temperature was 35℃and the detection wavelength was 210 nm.Results Scopolamine hydrobromide and atropine sulfate were completely separated from adjacent impurity peaks;scopolamine hydrobromide showed a good linear relationship in the range of 0.002146-0.10729 mg/mL;atropine sulfate showed good linearity in the range of 0.002071-0.10354 mg/mL.The average recoveries were 100.04%and 98.91%,RSDs were 5.86%and 5.54%(n=9).Conclusion This method can effectively determine the content of Hyoscyamus Niger Extract in Weitongning Tablets,which provides a reference for the quality control of Weitongning Tablets.

关 键 词：高效液相色谱法 胃痛宁片 天仙子浸膏 氢溴酸东莨菪碱 硫酸阿托品 含量测定 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]