妇科千金片HPLC特征指纹图谱及多成分含量测定

发布时间：2018-09-14 14:34

【摘要】：目的:建立妇科千金片的指纹图谱,并进行多成分定量分析,为评价其质量提供依据。方法:采用Sunfire C_(18)色谱柱(4.6 mm×250 mm,5μm),流动相0.1%磷酸水溶液-乙腈梯度洗脱,流速1.0 m L·min~(-1),检测波长(0~12 min,326 nm;12~18 min,316 nm;18~24 min,225 nm;24~50 min,254 nm),柱温30℃,进样量10μL。通过相似度评价结合聚类分析对11批次妇科千金片指纹图谱进行质量评价。结果:在特征图谱研究中,共确定妇科千金片HPLC指纹图谱14个共有峰,通过与混合对照品比较指认其中5个指标成分,分别是绿原酸、阿魏酸、穿心莲内脂、盐酸小檗碱和脱水穿心莲内酯,利用相似度软件对11批样品指纹图谱进行分析,各批样品相似度均0.90。结论:所建立的妇科千金片HPLC指纹图谱和含量测定分析方法灵敏度高,专属性强,可用于妇科千金片的质量控制。
[Abstract]:Objective: to establish the fingerprint of gynecological Qianjin tablets and to provide basis for its quality evaluation. Methods: Sunfire C18 column (4.6 mm 脳 250 mm,5 渭 m),) was used as mobile phase of 0.1% phosphoric acid aqueous solution and acetonitrile gradient elution. The flow rate was 1.0 mL min~ (-1). The fingerprint of 11 batches of gynecological Qianjin tablets was evaluated by similarity evaluation and cluster analysis. Results: the HPLC fingerprint of gynecological Qianjin tablets had 14 common peaks, and five of them were identified as Lv Yuan acid, ferulic acid, andrographolide by comparison with the mixed reference substance. Berberine hydrochloride and dehydrated andrographolide were used to analyze the fingerprint of 11 batches of samples. Conclusion: the established HPLC fingerprint and content determination method for gynecological Qianjin tablets have high sensitivity and specificity, and can be used for the quality control of gynecological Qianjin tablets.
【作者单位】：江苏省南通卫生高等职业技术学校;
【分类号】：R286.0;O657.72

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