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目的:建立注射用单磷酸阿糖腺苷中有关物质的测定方法。方法:采用高效液相色谱法,Dikma C18柱(4.6mm×250mm,5μm),以甲醇-水(0.1 mol.L-1磷酸二氢钾-0.01mol.L-1四丁基氢氧化铵)(15∶85)为流动相;检测波长260nm;流速为1.0mL.min-1。结果:在该色谱条件下,单磷酸阿糖腺苷与各杂质分离良好。其中的特殊杂质腺嘌呤、阿糖腺苷在0.5～50μg.mL-1的范围内,线性关系良好,回收率分别为99.9%(RSD=0.66%)和100.0%(RSD=0.57%)(n=9)。结论:该方法简便、快捷、准确,可以有效地控制产品质量。
Objective: To establish a method for the determination of related substances in vidarabine monophosphate for injection. Methods: High performance liquid chromatography (HPLC) was performed on a Dikma C18 column (4.6 mm × 250 mm, 5 μm) with methanol-water (0.1 mol·L -1 potassium dihydrogen phosphate -0.01 mol·L -1 tetrabutylammonium hydroxide) : 85) as mobile phase; detection wavelength 260nm; flow rate 1.0mL.min-1. Results: Under this chromatographic condition, the arabinosyl monophosphate separated well from each impurity. Among them, adenine and arabinoside, the special impurities, had a good linearity in the range of 0.5 ~ 50μg.mL-1 and the recoveries were 99.9% (RSD = 0.66%) and 100.0% (RSD = 0.57% = 9). Conclusion: The method is simple, fast and accurate, and can effectively control product quality.