更昔洛韦含量及有关物质的HPLC测定

HPLC Determination of Content and Related Substances of Ganciclovir

目的:改进更昔洛韦含量及有关物质的测定方法。方法:采用高效液相色谱法测定更昔洛韦的含量及有关物质,并与薄层色谱法和非水滴定法测定含量和有关物质的结果进行比较。结果:高效液相色谱法:更昔洛韦与其鸟嘌呤、异构体及其他降解产物分离度良好,含量测定在0.01～0.15 mg·mL^(-1)的浓度范围内线性良好(r=0.9999)。结论:高效液相色谱法与薄层色谱法及非水滴定法的测定结果基本一致,高效液相色谱法简便、专属性强,更适用于更昔洛韦含量及有关物质的测定。

Objective：To improve the determination of content and related substances of ganciclovir. Methods： HPLC was used to determine the content and related substances of ganciclovir, and the results were compared to those of the methods of thin layer chromatography and titration in non - aqueous solvent. Results： HPLC method ： ganciclovir was successfully separated from bird - purine,isomer and other degradation products. A linearity was obtained with good correlation （r =0. 9999） in the range of concentration from 0. 01 mg·mL^-1 to 0. 15 mg·mL^-1 Conclusion： The result of HPLC method is consistent with those of the methods of thin layer chromatography and titration in non - aqueous solvent. However, HPLC method is more convenient and specific, therefore, is more suitable in determining the content and related substances of ganciclovir.