The Comparison Between HPLC And EMIT For Determination Of Norvancomycin In Human Plasma And The Correlation Analysis Study Of The Results By Patients’ Determination Of Norvancomycin

Norvancomycin belong to glycopeptide antibiotics,and it is similar in chemical structure to vancomycin.So its antimicrobial spectrum and antimicrobial effects are similar to vancomycin. Glycopeptide antibiotics are the drugs of first choice to treat gram-positive bacteria,especially MASA.With the increasing of infections of MRSA and MRSE, norvancomycin is used more and more frequently.The adverse reactions of norvancomycin are serious, and the therapeutic window of norvancomycin is narrow. Therefore,to do TDM of norvancomycin is very necessary.By now, the methods for determination of norvancomycin have FPIA,HPLC.And a few experimenters use LC-MS/MS,EMIT,and so on.These methods have their own advantages and disadvantages.We need a simple,rapid and exact method of norvancomycin in dayly TDM.Objective: To establish methods for determination of norvancomycin in human plasma by HPLC and EMIT,and to study the correlation of the two methods.Analysis study the clinic correlation,then provide theoretical foundation for rational use of norvancomycin in clinic.Methods:The comparison among different determinations of norvancomycin:establish methods for determination of norvancomycin in human plasma by HPLC and EMIT,and verify the precision,accuracy and stability of the two methods respcetively.Collect pations’ plasma who have been treated by norvancomycin,and determinate by HPLC and EMIT. Analysis the results,and compare the correlation.the correlation analysis study of the results by patients’ determination of norvancomycin : Determinate norvancomycin in pations’ plasma by EMIT.Analysis and compare the correclation of the results, ages,renal functions,drug combinations and basic diseases,and so on.Results:HPLC : The retentions time of Norvancomycin and vancomycin are 8.0min, 11.0min.The standard curve is Y=0.0207C-0.0003, r= 0.9997,the linearity range is 2~100 μg/ml,the LOD is 2μg/ml.The recovery averages(%)of low,middle,high concentration(4、40、80μg/ml)are 101.6±10.09,107.2±2.23,107.7±1.53,both with-day RSD and day to day RSD are less than 15%.EMIT:The standard curve is Y=-3.4×10-7C3-9.5×10-6C2+0.0042C+0.3034, r=0.9999, the linearity range is 2~50μg/ml,the LOD is 2μg/ml.The linear regression equation of the results by HPLC and EMIT for determination of norvancomycin are Y= 0.9395X- 1.934( Y :EMIT/μg/ml,X:HPLC/μg/ml), r=0.9217.The result of paired t-test to compare the two data sets:P>0.05. Compare the normal SCr group and greater than normal SCr group:P<0.05. Compare age 60~75 group and age >75 group: P<0.05.Conclusion: The correlation of the results by HPLC and EMIT for determination of norvancomycin are preferable.The plasma concentrations are correlate with ages,renal functions,basic diseases and combined use of antibiotics,and so on. TDM is very nessisary.