摘要
建立康艾注射液UPLC指纹图谱,对不同批次制剂进行质量评价。采用超高效液相色谱(UPLC)技术,通过建立康艾注射液的UPLC-UV指纹图谱分析方法,确定并指认了14个共有峰。该方法的主要色谱参数包括Agilent ZORBAX Eclipse XDB-C18色谱柱(50 mm×4.6 mm,1.8μm);柱温30℃;乙腈水系统梯度洗脱,流速1 mL/min;检测波长205 nm。研究结果表明,该方法准确、重复性良好。应用该方法对30批次的康艾注射液进行了相似度评价,结果显示各批次制剂相似度良好。本研究指纹图谱分析方法的建立和应用可为康艾注射液产品的均一、稳定提供充分保障。
UPLC fingerprint of Kang'ai injection was established to carry out the quality evaluation of different batches of preparations.UPLC-UV fingerprint of Kang'ai injection was established by UPLC and 14 common peaks in chromatograms were designated and identified.Main chromatographic parameters were optimized and determined as follows,Agilent ZORBAX Eclipse XDB-C18 column(50 mm×4.6 mm,1.8μm)at 30℃was applied to separate the sample by elution with an acetonitrile-water gradient system at a flow rate of 1 mL/min and detection wavelength of 205 nm.The methodological study showed that the method is accurate and reproducible.The similarity of 30 batches ofKang'ai injection was evaluated by this method and a higher similarity between batches was observed.The establishment and application of the fingerprint analysis method could provide a sufficient guarantee for the uniform and stable quality of Kang'ai injection.
作者
刘悦
解生旭
蔡利剑
王道新
翁红
徐雅娟
LIU Yue;XIE Shengxu;CAI Lijian;WANG Daoxin;WENG Hong;XU Yajuan(Key Laboratory of Effective Substances Basis of Traditional Chinese Medicine,Jilin Academy of Chinese Medicine Sciences,Changchun 130012,China;Changbaishan Pharmaceutical co.,Ltd,Jilin 132500,China)
出处
《特产研究》
2023年第2期110-115,共6页
Special Wild Economic Animal and Plant Research
基金
吉林省科技发展计划基金项目(20200504007YY)。
