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作 者:潘涛[1] 欧阳波[1] 肖作奇 田霞[1] 黄懿[1]
出 处:《中国医院药学杂志》2015年第13期1191-1195,共5页Chinese Journal of Hospital Pharmacy
基 金:湖南省中医药管理局科研项目(编号:2013143;201516)
摘 要:目的:建立产康乐颗粒HPLC指纹图谱及4种成分含量测定方法,为质量控制提供依据。方法:Hypersil ODS2色谱柱(4.6 mm×250 mm,5μm),以0.1%磷酸水溶液和乙腈为流动相,梯度洗脱,检测波长为280 nm。结果:建立了产康乐颗粒的指纹图谱,确立了20个共有峰,10批成品指纹图谱相似度在0.95以上;同时对其4个有效成分进行了含量测定。结论:建立的HPLC指纹图谱及含量测定方法符合相关要求,适合产康乐颗粒的质量控制。OBJECTIVE To establish HPLC fingerprints of Chankangle granules,and give a new method for quality control of Chankangle granules.METHODS HPLC was used on a Hypersil ODS2 C18column(4.6 mm×250 mm,5μm)and diode array detector with gradient elution solvent system composed of acetonitrile-0.1% H3PO4 water solution;the detection wavelength was 280 nm.RESULTS HPLC fingerprints of Chankangle granules were established.Twenty common peaks were selected as the fingerprint peaks,and four common peaks were used for quantitative analysis.The similarity between fingerprints of ten batches were greater than0.95.CONCLUSION The established HPLC fingerprint has desirable precision,reproducibility and stability,and can be applied to for quality control of Chankangle granules.
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