| 引用本文: | 文春梅,郑舒娴,王建.HPLC测定二维芦丁片复方制剂中芦丁的溶出度和含量[J].中国现代应用药学,2018,35(2):188-192. |
| WEN Chunmei,ZHENG Shuxian,WANG Jian.Determination of Dissolution and Content of Two-dimensional Rutin Tables by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(2):188-192. |
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| 摘要: |
| 目的 建立HPLC测定二维芦丁片中芦丁溶出度和含量的方法。方法 溶出度测定以水（含0.5% SDS）为溶出介质，浆法，转速为75 r·min-1，45 min取样，取样后采用HPLC测定；含量测定采用Thermo C18柱（4.6 mm×250 mm，5 μm），以磷酸盐缓冲液（0.l mol·L-1磷酸二氢钠溶液，用磷酸调节pH值至4.4）-乙腈（80∶20）为流动相，检测波长为254 nm。结果 芦丁在2.26~22.56 μg·ml-1内与峰面积线性关系良好（r=1.000 0），平均回收率为98.2%（RSD=0.4%），溶出液稳定。3批样品在45 min时平均溶出度均>75%，并且有较好的均一性；含量测定线性关系良好，芦丁回收率为100.6%（RSD=0.4%，n=9）。结论 该法简单、准确、重复性好，可用于二维芦丁片中芦丁的溶出度及含量的测定。 |
| 关键词: 二维芦丁片 芦丁 溶出度 含量 高效液相色谱法 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.02.008 |
| 分类号:R917.101 |
| 基金项目:国家药品标准提高研究项目（食药监药化管便函[2015]1057号） |
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| Determination of Dissolution and Content of Two-dimensional Rutin Tables by HPLC |
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WEN Chunmei1, ZHENG Shuxian1, WANG Jian2
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1.Zhejiang University of Technology, Hangzhou 310014, China;2.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To determine dissolution and content of rutin in two-dimensional rutin tablets by HPLC. METHODS The dissolution medium of determination of dissolution was water (containing 0.5% SDS). Apparatus 2 was used with 75 r·min-1. The dissiution medium was taken and analyzed by HPLC at 45 min. Determination of content was measured using a Thermo C18 column. The mobile phase was treated with phosphate buffer (0.l mol·L-1 sodium dihydrogen phosphate solution and adjusted to pH 4.4 with phosphoric acid)-acetonitrile (80:20). The detection wavelength was 254 nm. RESULTS Dissolution determination:it showed that stardard curve was linear in the range of 2.26-22.56 μg·ml-1(r=1.000 0). The average recovery was 98.2% (RSD=0.4%) for rutin. The disslution of two-dimensional rutin tablets from three batches were >75%. Determination of content:the method for determination of rutin had a good linearity, and the recovery was 100.6%(RSD=0.4%, n=9). CONCLUSION The method is simple, sensitive and reproducible, and it can be used for the determination of dissolution and content of two-dimensional rutin tablets. |
| Key words: two-dimensional rutin tablets rutin dissolution content HPLC |
