建立差示扫描量热法测定比沙可啶原料药样品纯度的方法。考察了炉体气氛、升温速率、称样量3个因素对差示扫描量热法测定结果的影响，确定差示扫描量热法最佳实验条件：升温速率为2.0 K／min，称样量为2.0～4.0 mg，炉内气体为静态空气。差示扫描量热法测定比沙可啶样品纯度为99.86%，测定结果的相对标准偏差为0.02%(n=6)，差示扫描量热法测定比沙可啶样品纯度值与 HPLC 测定结果具有良好的一致性。该方法可以快速、准确地测定比沙可啶化学纯度，为比沙可啶纯度测定提供了一种新的分析方法。%A method for determination of the purity of bisacodyl by differential scanning calorimetry(DSC) was established. Considering of three factors in experiment of Bisacodyl’s purity by using the DSC method, an optimization experiment conditions was obtained as the following: the heating rate was at 2.0 K/min,the sample mass was 2.0~4.0 mg, furnace gas was static air. The purity of bisacodyl determined by DSC was 99.86%,and the relative standard deviation of determination results was 0.02%(n=6). The measurement result by differential scanning calorimetry was shown good consistency with HPLC. This method can quickly and accurately determine the chemical purity of bisacodyl,which provides a new analysis method for the determination of purity of bisacodyl.
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