摘要
目的建立高效液相色谱(HPLC)双波长法同时分离测定复方枇杷喷托维林颗粒中的枸橼酸喷托维林、甘草酸和甘草次酸,为药物质量标准的提高提供理论依据。方法本研究于2019年6月至2020年5月在西安市食品药品检验所化学实验室进行。采用热电C18色谱柱(250 mm×4.6 mm,5μm),甲醇–1%三乙胺水溶液(磷酸调节pH为3.0)二元梯度洗脱,流速1.0 mL/min,进样量10μL,检测波长215 nm和250 nm。结果三种组分分别在10.24~511.97μg/mL、4.89~244.74μg/mL和0.50~25.12μg/mL浓度范围内线性关系良好,枸橼酸喷托维林、甘草酸和甘草次酸的平均回收率分别为102.27%,99.94%和98.02%,相应的RSD为2.31%~2.42%。结论本法简便、准确,灵敏度高,可用于复方枇杷喷托维林颗粒的质量控制。
Objective To develop a double–wavelength high performance liquid chromatography(HPLC)method for simultaneous separation and determination of pentoryverine citrate,glycyrrhizic acid and glycyrrhetinic acid in compound loquat and pentoryverine granules,inordertoprovideatheoreticalbasisfortheimprovementofthedrugstandard.Methods Thestudywasconductedinthechemical laboratory of Xi'an Institute for Food and Drug Control from June 2019 to May 2020.HPLC separations were carried out on a Thermo C_(18) column(250 mm×4.6 mm,5μm)with a binary gradient elution of methanol–1%triethylamine(pH adjusted to 3.0 by phosphoric acid)at a flow rate of 1.0 mL/min.The injection volume was 10μL and the detection wavelengths were 215 nm and 250 nm.Results Good linear relationships between the peak area and concentration were found in the ranges of 10.24–511.97μg/mL,4.89–244.74μg/mL and 0.50–25.12μg/mL for three components,respectively.The average recoveries of pentoryverine citrate,glycyrrhizic acid and glycyrrhetinic acid were 102.27%,99.94%and 98.02%,respectively,with the RSDs ranging from 2.31%to 2.42%.Conclusion The method is simple,accurateandsensitive.Itcanbeusedforthequalitycontrolofthecompoundloquatandpentoryverinegranules.
作者
任静
杜晖
REN Jing;DU Hui(Department of Pharmacy,The Second Affiliated Hospital of The Fourth Military Medical University(Air Force Medical University)of PLA,Xi′an,Shaanxi 710038,China;Xi′an Institute for Food and Drug Control,Xi′an,Shaanxi 710054,China)
出处
《安徽医药》
CAS
2022年第1期26-29,共4页
Anhui Medical and Pharmaceutical Journal
基金
陕西省创新人才推进计划(2018KJXX–089)
国家药典委员会药品标准提高项目(2019H087)
关键词
色谱法
高压液相
主成分分析
镇咳药
复方枇杷喷托维林颗粒
甘草酸
甘草次酸
Chromatography,high pressure liquid
Principal component analysis
Antitussive agents
Compound loquat and Pentoryverine granules
Glycyrrhizic acid
Glycyrrhetinic acid
