中国药房2011，Vol.22Issue(9)：841-843,3.
高效液相色谱-荧光检测法测定瑞格列奈片含量及其溶出度研究
Dissolution and Content Determination of Repaglinide Tablets by HPLC-Fluorescence Detection
宁美英 1刘彦 2何小稳 2李岑 2蒋晔2
作者信息
- 1. 河北沧州市中心医院药剂科,沧州市,061001
- 2. 河北医科大学药学院,石家庄市,050017
- 折叠
摘要
Abstract
OBJECTIVE: To establish the method for the trace determination and dissolution study of Repaglinide tablets. METHODS: HPLC-fluorescence detection was adopted. A separation was performed on Kromasil C18 column, the mobile phase was 0.5％ phosphonic acid (pH adjusted to 2.5)-methanol-acetonitrile (40: 10:50) with the flow rate at 1.0 mL·min-1. The column temperature was 40 ℃ and injection volume 20 μL. The wavelengths of excitation and emission were set at 244 nm and 348 nm, respectively. The dissolution of Repaglinide tablets was detected by paddle method using citric acid-phosphate buffer solution (pH=5.0 ) as solvent at rotation speed of 75 r·min-1. The accumulative dissolution of 3 batches of samples was determined. RESULTS: The linear range of repaglinide was 0.055～1.76 μg.mL-1 (r=0.999 7) with average recoveries of 98.8％, 99.4％ and 99.6％ at low, medium and high concentration (RSD= 1.4％, 1.3％, 1.5％ ). The quantitative limit was 0.21 ng and detection limit was 0.05 ng. The accumulative dissolution of 3 batches of samples at 30 min was 89.6 ％ ～93.4 ％. CONCLUSION: The method is sensitive and specific for the trace determination and dissolution of repaglinide.关键词
瑞格列奈片/痕量测定/高效液相色谱-荧光检测法/累积溶出度分类
医药卫生引用本文复制引用
宁美英,刘彦,何小稳,李岑,蒋晔..高效液相色谱-荧光检测法测定瑞格列奈片含量及其溶出度研究[J].中国药房,2011,22(9):841-843,3.
