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机构地区:[1]天津药物研究院,天津300193 [2]天津世纪天龙药业有限公司,天津300000
出 处:《中国实验方剂学杂志》2015年第21期66-69,共4页Chinese Journal of Experimental Traditional Medical Formulae
基 金:天津市科技计划项目(12ZCDZSY11600;14ZCZDSY00005);天津市应用基础与前沿技术研究计划(14JCQNJC13800)
摘 要:目的:建立龙加通络胶囊的HPLC和UPLC特征指纹图谱分析方法,比较UPLC与HPLC分析龙加通络胶囊指纹图谱的效果,为快速评价龙加通络胶囊的质量,完善其质量控制方法提供依据。方法:UPLC色谱系统采用Agilent Poroshell120 Bonus-RP色谱柱(3.0 mm×50 mm,2.7μm),流动相乙腈-水溶液,梯度洗脱,检测波长203 nm,柱温25℃;HPLC色谱系统采用Agilent Zorbox ODS色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-水溶液,梯度洗脱,检测波长203 nm,柱温35℃;并分别采用UPLC与HPLC对10批龙加通络胶囊进行指纹图谱分析。结果:分别建立了龙加通络胶囊的UPLC与HPLC指纹图谱共有模式。以薯蓣皂苷为参照峰,其中UPLC标识出17个共有峰,HPLC标识出13个共有峰,10批样品的相似度均>0.9。结论:2种方法均可用于龙加通络胶囊质量控制,分离效果好、稳定性高、重复性好,UPLC较HPLC更高效、快速、灵敏。Objective: To establish and compare the UPLC and HPLC fingerprints of Longjia Tongluo capsules( LTC),and provide basis for quickly assessing the quality of Longjia Tongluo capsules and improving their quality control. Method: UPLC separation was performed on a Agilent Poroshell 120 Bonus-RP column( 3. 0mm × 50 mm,2. 7 μm) at 25 ℃ through gradient elution with acetonitrile-water mixture and detection at a wavelength of 203 nm. HPLC separation was performed on a Agilent Zorbox ODS column( 4. 6 mm × 250 mm,5μm) at 35 ℃ through gradient elution with acetonitrile-water mixture and detection at a wavelength of 203 nm.HPLC and UPLC methods were used respectively to analyze the fingerprint of 10 batches of Longjia Tongluo capsules. Result: The common mode of UPLC and HPLC was established for Longjia Tongluo capsules. Taken Dioscin as the reference peak,17 common peaks were identified in UPLC chromatography and 13 common peaks were identified in HPLC chromatography. The similarity of 10 batches of samples was over 0. 9. Conclusion: Both the UPLC and HPLC methods could be used for the quality control of Longjia Tongluo capsule,with good separation effect,reproducibility and stability. Compared to HPLC,the UPLC method is more efficient,rapid,and sensitive.
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