复方单硝酸异山梨酯缓释片中单硝酸异山梨酯的释放度测定

Release Rate Determination of Isosorbide Mononitrate in Compound Isosorbide Mononitrate Sustained Release Tablets

目的建立高效液相色谱法,测定复方单硝酸异山梨酯缓释片中单硝酸异山梨酯的释放度。方法以pH=5.0的磷酸盐缓冲液250mL为溶剂,转速为100r/min。以高效液相色谱法测定含量,色谱柱为Luna ODS C18柱(250mm×4.6mm,5μm),流动相为1%醋酸溶液(加0.1%三乙胺)-甲醇(55:45),检测波长230nm,流速1.0mL/min。结果单硝酸异山梨酯质量浓度线性范围为19.66～314.56μg/mL(r=0.9999),平均回收率为100.27%,RSD=1.78%(n=9);体外释放符合Higuchi方程,与国外对照样品一致。结论该方法简便、准确,可作为复方单硝酸异山梨酯缓释片的释放度测定方法。

Objective To establish a method of release rate determination of isosorhide mononitrate in Compound Isosorbide Mononitrate Sustained Release Tablets by HPLC. Methods Dissolution medium was pH =5.0 phosphate buffer 250 mL and rotating speed was 100 r/min. The chromatographic method was carried out on LUNA ODS C18 column using 1% acetic acid solution（0. 1% triethylamine） -methanol （55：45） as the mobile phase. The detection wavelength was set at 230 nm. The flow rate was 1.0 mL/min. Results The linear range was 19.66 - 314.56 μg/mL（ r = 0. 999 9）. The average recovery rate was 100. 27% with RSD = 1.78% （ n = 9）. The drug release profile in vitro was followed Higuchi model equation, which was compatible with the imported tablets. Conclusion The simple and accurate method to determine release rate of isosorbide mononitrate in Compound Isosorbide Mononitrate Sustained Release Tablets is established.