摘要
目的建立采用外标法测定硝酸异山梨酯原料含量的方法。方法色谱柱为Kromasi1(150mm×4.6mm5μm);流动相为甲醇-水(54:46),检测波长为230nm,流速为1ml·min^-1。结果硝酸异山梨酯在0.02008-0.3012mg.ml^-1范围内线性关系良好,r=0.9999,平均回收率为99.8%,RSD为0.47%(n=9)。结论该方法简便、快速,重现性好。
OBJECTIVE External Standard method for determination of Isosorbide Dinitrate was established. METHODS The chromatographic system consisted of Kromasil (150mm×4.6mm 5μm) and mobile phase of methanol-water (54: 46) with. a detection wavelength at 230nm The flow rate was 1ml· min^-1.RESULTS The linear range was 0.02008--0.3012mg· ml^-1 (r=0.9999) .The average recovery was 99.8%, RSD was 0.47% (n=9) .CONCLUSION The method was simple, rapid and reproducible.