Content Determination of Related Substances in Oxaliplatin by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish the HPLC method for the determination of the related substances in oxaliplatin.METHODS:The chromatographic separation was performed on C18,and the mobile phase consisted of methyl alcohol and water(5∶95)with a flow rate of 1.0 mL?min-1.The column temperature was 25 ℃;the detection wavelength was 250 nm and the sample size was 20 ?L.RESULTS:A good linear relationship was obtained for oxaliplatin within the concentration range of 5～17.5 ?g?mL-1(r=0.999 9)with a limit of quantitation of 3 ng(S/N=3).The average content in 3 batches of crude drug vs.their preparations was 0.081% vs.0.15%.CONCLUSION:This method is accurate,reliable and available,and suitable for the content determination of the related substances in oxaliplatin.