HPLC法同时快速测定伐昔洛韦、泛昔洛韦和更昔洛韦含量  

Simultaneous determination of ganciclovir, valacyclovir and famciclovir by HPLC

作　　者：孔爱英[1] 纪宏[2] 韩杰[3] 朱文凤[1] 

机构地区：[1]总后卫生部药品仪器检验所,北京100166 [2]北京市药品检验所,北京100035 [3]北京师范大学分析测试中心,北京100875

出　　处：《中国抗生素杂志》2015年第8期607-610,共4页Chinese Journal of Antibiotics

摘　　要：目的 建立同时快速测定伐昔洛韦、泛昔洛书和更昔洛韦3种化合物含量的分析方法。方法 采用c18色谱柱，流动相：甲醇．0．03mol／L磷酸二氢铵溶液（用磷酸调节pH值至3．0±0．1）V：V=35：65）；流速：1．0mL／min，柱温：35℃，检测波长为250nm，结果 更昔洛韦、伐昔洛韦和泛昔洛韦浓度分别在9．88～59．28、9．48～56．88和20．08～120．48gg／mL范围内，与其峰面积呈良好线性关系，线性方程分别为：A=6．71×104C＋7．91×104（R2=0．99971，A=4．89×104C＋6．94×104（R2=0．9997）．A=I．06×10^4Cl＋3．82×10^4（R2＝0．9995）加标回收率分别为99．7％（RSD为1．0％）、100．4％（RSD为1．2％）和9．3％（RSD为1．1％）（n=9）；样品溶液在6h内稳定。结论建立的方法简便、准确，可同时测定核苷类抗病毒药物的含量。Objective To establish an HPLC method for simultaneous determination of ganciclovir,valacyclovir and famciclovir. Methods The assay was conducted on C18 column. The detector wavelength was250nm. The mobile phase consisted of 0.03mol/L NHgH2PO4（adjusted to pH（3.0±0.1） with phosphoric acid-acetonitrile（6535）. The flow rate was 1.0mL/min and the column temperature was 35℃. Results The calibration curve ofganciclovir, valacyclovir and famciclovir were linear in the range 9.88-59.28, 9.48-56.88 and 20.08-120.48gg/mL,respectively. The average recovery rates were 99.7%（RSD=1.0%）, 100.4%（RSD=1.2%） and 99.3%（RSD=1.1%）（n=9）,respectively. The reproducibility and precision of the method were good （RSD 〈 1%）. Conclusion This method isaccurate, simple and quick, which is suitable for the quality control of ganciclovir, valacyclovir and famciclovir.

关 键 词：更昔洛韦 伐昔洛韦 泛昔洛韦 高效液相色谱法 

分 类 号：R978.7[医药卫生—药品]