高效液相色谱法同时测定骨松宝丸中5种成分含量  

Simultaneous Determination of Five Components in Gusongbao Pills by HPLC

作　　者：孙桐 SUN Tong(Huai′an Food and Drug Inspection Institute,Huai′an,Jiangsu,China 223300)

机构地区：[1]江苏省淮安市食品药品检验所,江苏淮安223300

出　　处：《中国药业》2023年第8期69-73,共5页China Pharmaceuticals

摘　　要：目的建立同时测定骨松宝丸中5种成分含量的高效液相色谱(HPLC)法。方法色谱柱为Diamonsil C_(18)柱(150 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为210 nm(淫羊藿苷、川续断皂苷Ⅵ、吉马酮)、233 nm(芍药苷、阿魏酸),柱温为30℃,进样量为10μL。结果淫羊藿苷、川续断皂苷Ⅵ、芍药苷、阿魏酸和吉马酮质量浓度分别在10.180~203.60μg/mL(r=1.0000),0.522~10.44μg/mL(r=0.9999),1.274~25.47μg/mL(r=0.9996),1.260~25.20μg/mL(r=0.9996),0.517~10.34μg/mL(r=0.9998)范围内与峰面积线性关系良好;定量限分别为0.33,0.44,0.09,0.11,0.39μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为98.69%,95.88%,98.09%,97.68%,96.97%,RSD分别为1.66%,3.89%,2.14%,2.34%,3.36%(n=6)。结论该方法简便、准确、重复性好,可用于骨松宝丸的质量控制。Objective To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of five components in Gusongbao Pills.Methods The chromatographic column was Diamonsil C_(18) column(150 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was set at 210 nm(icariin,asperosaponinⅥand germacrone)and 233 nm(paeoniflorin and ferulic acid),the column temperature was 30℃,and the injection volume was 10μL.Results The linear ranges of icariin,asperosaponin Ⅵ,paeoniflorin,ferulic acid and germacrone were 10.180-203.60μg/mL(r=1.0000),0.522-10.44μg/mL(r=0.9999),1.274-25.47μg/mL(r=0.9996),1.260-25.20μg/mL(r=0.9996),0.517-10.34μg/mL(r=0.9998),respectively.The limits of quantitation(LOD)were 0.33,0.44,0.09,0.11,0.39μg/mL.The RSDs of precision,stability and repeatability tests were lower than 2.0%. The average recoveries of icariin,asperosaponin Ⅵ ,paeoniflorin,ferulic acid and germacrone were 98. 69%,95. 88%,98. 09%,97. 68% and 96. 97% with RSDs of 1. 66%,3. 89%,2. 14%,2. 34% and 3. 36%(n = 6),respectively. Conclusion The method issimple,accurate and reproducible,which can be used for the quality control of Gusongbao Pills.

关 键 词：骨松宝丸 淫羊藿苷 川续断皂苷Ⅵ 芍药苷 阿魏酸 吉马酮 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]