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作 者:刘天竹 李成森 刘博琳 李虹 周春玲 LIU Tianzhu;LI Chengsen;LIU Bolin;LI Hong;ZHOU Chunling(Liaoning Inspection,Examination&Certification Centre·Liaoning Institute for Drug Control,Shenyang,Liaoning,China 110000;College of Pharmacy,China Medical University,Shenyang,Liaoning,China 110000)
机构地区:[1]辽宁省检验检测认证中心·辽宁省药品检验检测院,辽宁沈阳110000 [2]中国医科大学药学院,辽宁沈阳110000
出 处:《中国药业》2021年第15期78-81,共4页China Pharmaceuticals
基 金:国家药典委员会药品标准修订研究课题[2019Z036]。
摘 要:目的建立同时测定芒果苷、升麻素苷、5-O-甲基维斯阿米醇苷、肉桂酸和芍药苷含量的高效液相色谱法。方法色谱柱为Agilent SB C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为1.0 m L/min,检测波长为254 nm,柱温为35℃,进样量为10μL。结果芒果苷、升麻素苷、5-O-甲基维斯阿米醇苷、肉桂酸和芍药苷的质量浓度分别在5.10~101.90μg/m L(r=0.999 9),9.66~193.20μg/m L(r=0.999 9),9.56~191.20μg/m L(r=0.999 8),9.88~197.60μg/m L(r=0.999 9),98.85~1 977.00μg/m L(r=0.999 9)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于2.0%(n=6);平均加样回收率分别为95.26%,96.88%,98.97%,94.86%,95.55%,RSD分别为1.05%,0.82%,1.38%,0.72%,0.66%(n=6)。结论该方法操作简便,结果准确,重复性好,可用于寒热痹颗粒的质量控制。Objective To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of mangiferin,cimicifugin,5-O-methylvisamminoside,cinnamic acid and paeoniflorin in Hanrebi Granules.Methods The chromatographic column was Agilent SB C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 35℃,and the injection volume was 10μL.Results The linear ranges of mangiferin,cimicifugin,5-O-methylvisamminoside,cinnamic acid and paeoniflorin were 5.10-101.90μg/mL(r=0.9999),9.66-193.20μg/mL(r=0.9999),9.56-191.20μg/mL(r=0.9998),9.88-197.60μg/mL(r=0.9999)and 98.85-1977.00μg/mL(r=0.9999),respectively.The RSDs of precision,stability and repeatability tests were less than 2.0%(n=6).The average recoveries of mangiferin,cimicifugin,5-O-methylvisamminoside,cinnamic acid and paeoniflorin were 95.26%,96.88%,94.51%,98.97%,95.55%with RSDs of 1.05%,0.82%,1.38%,0.72%,0.66%(n=6),respectively.Conclusion The method is simple,accurate and reproducible,which can be used for the quality control of Hanrebi Granules.
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