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目的采用HPLC法测定盐酸烟酰美金刚胺中的烟酸及其他有关物质。方法采用Luna SILICA色谱柱(150 mm×4.6 mm,5μm),以正庚烷-乙醇-冰乙酸(90∶10∶1)为流动相,检测波长260 nm。结果烟酰美金刚胺与烟酸及其他降解产物的分离度良好;0.50~10.0μg·m L~(-1)盐酸烟酰美金刚胺、0.25~5.0μg·m L~(-1)烟酸与峰面积的线性关系良好,r分别为0.9997、0.9999;烟酸的检测限和定量限分别为0.12、0.39μg·m L~(-1),加样回收率为99.7%。结论所用方法专属性好、结果准确,可用于盐酸烟酰美金刚胺中烟酸及其他有关物质的测定。
Objective To determine nicotinic acid and other related substances in nicotinic acid memantine hydrochloride by HPLC. Methods The Luna SILICA column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase and the detection wavelength was 260 nm with n-heptane-ethanol-glacial acetic acid (90:10:1) as the mobile phase. Results The separation of nicotinic acid and nicotinic acid and other degradation products was good. The concentrations of nicotinic acid and memantine hydrochloride of 0.50-10.0μg · m L -1 and 0.25-5.0μg · m -1 -1 of cigarette smoke The linear relationship between acid and peak area was good, with r values of 0.9997 and 0.9999, respectively. The limits of detection and quantification limits of nicotinic acid were 0.12 and 0.39 μg · m L -1, respectively. The recoveries were 99.7%. Conclusion The method used has good specificity and accurate results and can be used for the determination of nicotinic acid and other related substances in nicotinic acid hydrochloride.