摘要
目的:建立RP-HPLC法测定更昔洛韦粉针剂含量及有关物质.方法: 采用Kromasil C18色谱柱(4.6 mm×200 mm,5 μm),以甲醇-水(10∶90)为流动相,流速为0.8 mL/min,检测波长为252 nm,柱温为25℃.结果:样品中更昔洛韦与有关物质分离良好,有关物质含量少.更昔洛韦浓度线性范围为5.22～52.20 mg/L,相关系数r=0.9998;平均回收率为100.1%,RSD=0.91%.结论:该法操作简便、快速、准确.
Objective： To establish a RP-HPLC meted for determination of content of ganciclovir injection and its related substances. Methods： Kromasil C18 column（4.6 mm× 200 mm, 5 μm） was used. The mobile phase consisted of methanol-water（10：90）, at a flow rate of 0.8 mL/min with the column temperature of 25 ℃. The detection wavelength was 252 nm. Results： Ganciclivir and its related substances in sample were well-separated and the content of the latter was much less. The linear range of ganciclovir concentration was 5.22 - 52.20 mg/L （ r = 0.9998）. The average recovery was 100.1% （ RSD = 0.91% ）. Conclusion： The method was simple, rapid and accurate.
出处
《药学进展》
CAS
2005年第11期520-522,共3页
Progress in Pharmaceutical Sciences
