HPLC法测定5—单硝酸异山梨酯缓释胶囊含量

Determination of Isosorbide 5—mononitrate sustained release capsule by HPLC

建立了高效液相色谱法测定5—单硝酸异山梨酯缓释胶囊中5—单硝酸异山梨酯的含量方法。采用十八烷基键合硅胶填充柱(250×4.6mm,10μm),以咖啡因为内标,甲醇—水(24:76)为流动相,流速为1.0ml/min,检测波长为210nm,柱温为室温。线性范围为80～600μg/ml,平均回收率为99.93%(RSD=0.61%),辅料和内标物对测定无干扰。

To establish a method using HPLC to determine the assay of Isosorbide 5— mononitrate (ISMN) in its sustained release capsules.The column:lichrosorb C 18 column (250 ×4.6mm,10μm),caffeine as internal standard,the mobile phase consists of methanol—water (24:76).The UV detection wavelength is 210nm,whereas flow rate 1.0ml/min.The calibration curves were linear in the range of 80～600μg/ml,the average recovery of ISMV is 99.93% where- as RSD=0.61%.