Improvement of Content Determination Method of Methotrexate for Injection by HPLC / 中国药房

ABSTRACT

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(14860.50.3)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 0.52～3.64?g?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.