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对5-单硝酸异山梨酯两种市售制剂的溶出度进行RP-HPLC外标法测定。流动相为甲醇-水(1∶3),检测波长220nm,线性范围2~80μg/ml,最低检测浓度0.1μg/ml,RSD小于1%。经非线性回归,证实缓释制剂的释药符合一级方程Dt=Dmax[70%(1-e-k(t-t0)+30%]。
The dissolution of two commercial isosorbide 5-mononitrate samples was determined by RP-HPLC external standard method. The mobile phase was methanol-water (1: 3). The detection wavelength was 220 nm. The linear range was 2-80 μg / ml. The lowest detection concentration was 0.1 μg / ml with RSD less than 1%. The results of non-linear regression showed that the release of sustained-release preparations accord with the first order equation Dt = Dmax [70% (1-e-k (t-t0) +30%].