HPLC测定二维芦丁片复方制剂中芦丁的溶出度和含量

Determination of Dissolution and Content of Two-dimensional Rutin Tables by HPLC

关键词:  二维芦丁片  芦丁  溶出度  含量  高效液相色谱法

Key words:  two-dimensional rutin tablets  rutin  dissolution  content  HPLC

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。

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.