摘要
目的建立同时测定扁蕾颗粒中马钱苷酸、当药苷、芒果苷、木犀草素、1,7-二羟基-3,8-二甲氧基酮含量的高效液相色谱法。方法色谱柱为Waters SunFire ODS C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.05%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为254 nm,柱温为30℃,进样量为10μL。结果马钱苷酸、当药苷、芒果苷、木犀草素、1,7-二羟基-3,8-二甲氧基酮的进样量分别在0.0206~0.4120μg、0.2010~4.0200μg、0.0080~0.1600μg、0.0566~1.1320μg、0.0150~0.3000μg范围内与峰面积线性关系良好(r≥0.9998,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6);平均加样回收率分别为96.24%,98.16%,96.67%,98.06%,97.84%,RSD分别为0.84%,0.89%,1.06%,0.92%,1.57%(n=6);5批样品中上述成分的含量分别为0.53~0.56 mg/g、8.30~8.44 mg/g、0.23~0.26 mg/g、1.06~1.11 mg/g、0.73~0.76 mg/g。结论该方法快捷简便、分别可靠、稳定性好,可用于扁蕾颗粒制剂的质量控制。
Objective To establish a high-performance liquid chromatography(HPLC)method for the simultaneous loganic acid,sweroside,mangiferin,luteolin,and 1,7-dihydroxy-3,8-dimethoxykozanone in Bianlei Granules.Methods chromatographic column was Waters SunFireODS C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.05%phosphoric acid solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The linear ranges of loganic acid,sweroside,mangiferin,luteolin and l,7-dihydroxy-3,8-dimethoxyxanthone were 0.0206-0.4120μg,0.2010-4.020μg,0.0080-0.1600μg,0.0566-1.1320μg,0.0150-0.3000μg(r≥0.9998,n=6),respectively.The RSDs of precision,stability,and repeatability test results were lower than 2.0%(n=6).The average recoveries were 96.24%,98.16%,96.67%,98.06%and 97.84%,with RSDs of 0.84%,0.89%,1.06%,0.92%,and 1.57%(n=6),respectively.The contents of the above components in the five batches of samples were in the ranges of 0.53-0.56 mg/g,8.30-8.44 mg/g,0.23-0.26 mg/g,1.06-1.11 mg/g,and 0.73-0.76 mg/g,respectively.Conclusion The method is fast,simple,stable,and reliable,which can be used for the quality control of Bianlei Granules.
作者
问静
石春兰
韩达斌
刘海青
刘安平
李维业
徐文胜
邹存生
刘学良
WEN Jing;SHI Chunlan;HAN Dabin;LIU Haiqing;LIU Anping;LI Weiye;XU Wensheng;ZOU Cunsheng;LIU Xueliang(Qinghai Center for Drug Evaluation and Inspection,Xining,Qinghai,China 810007;Xining Center for Food and Drug Inspection&Testing,Xining,Qinghai,China 810007;S&P Pharmaceutical Co.,Ltd.,Xining,Qinghai,China 810016)
出处
《中国药业》
CAS
2023年第21期90-93,共4页
China Pharmaceuticals
基金
青海省科技计划项目[2020-ZJ-747]。