柔筋胶囊HPLC指纹图谱及指标性成分含量测定

Study on HPLC Fingerprint and Determination of Multi-components of Roujin Capsule(柔筋胶囊)

目的:建立柔筋胶囊的HPLC指纹图谱,并测定其主要成分的含量,为柔筋胶囊的质量控制提供可靠方法。方法:采用Agilent TC-C18(250 mm×4.6 mm,5μm)色谱柱,乙腈-0.1%磷酸水溶液进行梯度洗脱,检测波长为220 nm,柱温为25℃,流速为1.0 mL/min。应用中药色谱指纹图谱相似度评价软件(2012版)对10批柔筋胶囊进行分析评价,建立柔筋胶囊的HPLC指纹图谱,并测定主要成分含量。结果:确定了15个共有峰,通过对照品比对指认了其中3个色谱峰,分别为没食子酸、大黄素和大黄酚,10批样品的相似度均大于0.99。定量测定的3种成分在各自线性范围内线性关系良好(r>0.999,6),平均加样回收率99.54%~101.94%,RSD为0.92%~1.86%。结论:所建立的HPLC指纹图谱和含量测定方法为柔筋胶囊的质量评价提供了科学依据。

Objective: To establish the HPLC fingerprint of Roujin Capsule, and determine the contents of of the main components to provide the basis for the quality control of Roujin Capsule. Methods: The chromatographic separation was performed on an Agilent TC-C18 column(250 mm×4.6 mm,5 μm) with gradient elution using acetonitrile and 0.1% phosphoric acid as the mobile phase. The detection was conducted at 220 nm. The column temperature was 25 ℃ at the flow rate of 1.0 mL/min. The HPLC fingerprint for 10 batches of Roujin Capsule was established using Similarity Evaluation Software for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 edition). Results: 15 common peaks were found, and 3 common peaks were identified by references including gallic acid, emodin and chrysophanol. The similarity of 10 batches samples was over 0.99.The 3 determined constituents showed good linearity in their respective linear ranges(r>0.999,6). The average recoveries ranged from 99.54%~101.94%, and the RSD ranged from 0.92% to 1.86%. Conclusions: The established method could provide reference for the quality evaluation of Roujin Capsule.