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Determination of mthylmesylate and ethylmesylate in nafamostat mesilate raw material by derivative GC-MS

LIU Xiaoqiang;DING Jian;Changzhou Center for Food and Drug Control;  
Objective To determinate mthylmesylate(MMS)and ethylmesylate(EMS)in nafamostat mesilate raw material by derivative GC-MS.Methods The MMS and EMS were determined by pre-column derivation by temperature programming method.Helium was used as the carrier gas.The content of MMS and EMS were quantified with butylmesylate as internal standard.Results The linear calibration curves of MMS and EMS were both obtained over the range of 3.0-200.0 ng·mL~(-1),the correlation coefficients were 0.997 5 and 0.999 9.The limits of detection were 0.964 3 and 1.007 8 ng·mL~(-1),the limits of quantitation were2.892 8 and 3.022 3 ng·mL~(-1).The RSDs of the injection precision were 0.9% and 1.3%.The extraction rates were 102% and106% with RSD of 2.9% and 1.2%.Conclusion The method is simple and convenient,quick and easy,and can be used for the quality control of MMS and EMS in nafamostat mesilate.
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