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目的建立HPLC法测定戊四硝酯粉及戊四硝酯片的有关物质。方法采用PhenomenixC18柱(5μm,150mm×4.6mm),以甲醇-水(54:46)(用磷酸调节pH值至3.0)为流动相;检测波长为230nm,流速为1ml?min-1。结果戊四硝酯粉及戊四硝酯片与相邻色谱峰的分离度符合要求,峰纯度检查为0.9999。结论本法专属性强,可用于戊四硝酯粉及戊四硝酯片有关物质的测定。
Objective To establish a HPLC method for the determination of pentylenetetramine ester and pentylenetetramine tablets. Methods The mobile phase consisted of Phenomenix C18 column (5μm, 150mm × 4.6mm) with methanol-water (54:46) (adjusted to pH 3.0 with phosphoric acid). The detection wavelength was 230nm and the flow rate was 1ml? Min-1. Results The separation of pentylenetetramine ester and pentylenetetramine ester from the adjacent chromatographic peaks was satisfactory. The peak purity was 0.9999. Conclusion This method is highly specific and can be used for the determination of related substances of pentylenetetramine ester powder and pentylenetetramine ester.