摘要
目的:改进注射用甲氨蝶呤(MTX)含量测定的高效液相色谱法。方法:以内标法代替《中国药典》采用的外标法进行注射用MTX的含量测定。色谱柱为InertsilC_8,流动相为乙腈-水-冰醋酸-三乙胺(14:86:0.5:0.3),紫外检测波长为306nm,流速为0.8mL·min^(-1),以甲硝唑为内标,并与外标法结果比较。结果:MTX检测浓度线性范围为0.52～3.64μg·mL^(-1)(r=0.9997),平均回收率为99.77%,RSD=0.42%。2种方法含量测定结果相似。结论:改进后的方法简便、准确、重复性好,可有效地控制MTX的质量。
OBJECTIVE：To improve the HPLC method for the content determination of Methotrexate（MTX）for injection.METHODS：The determination was performed on Inertsil C 8 column,mobile phase consisted of acetonitrile-water-acetic acid glacial-triethylamine（14：86：0.5：0.3）at flow rate of 0.8 mL·min^-1.UV detection wavelength was set at 306 nm.Metronidazolum was selected as internal standard for internal standard method to replace external standard method stated in Chinese Pharmacopeia.Result of internal standard method was compared with that of external standard method.RESULTS：The linear range of MTX was 0.52～3.64μg·mL-1（r=0.999 7）with an average recovery of 99.77%（RSD=0.42%）.Two kinds of methods obtained similar results.CONCLUSION：Improved method is convenient,accurate and reproducible for quality control of MTX.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第25期2382-2383,共2页
China Pharmacy
关键词
注射用甲氨蝶呤
HPLC法
改进
内标法
外标法
甲硝唑
Methotrexate for injection
HPLC method
Improvement
Internal standard method
External standard method
Metronidazole
