Standardization of the first batch of national reference standard of agomelatine
Objective:To establish the first batch of national reference standard of agomelatine for qualitative and quantitative determination.Methods:The structure of agomelatine was confirmed by IR,NMR an d GC-MS spectroscopy.The purity of agomelatine was determined by HPLC,and the homogeneity and stability were studied.Moreover,the drying weight loss and residual ignition were determined.The content of agomelatine was calculated by mass balance method.Results:The structure of agomelatine was confirmed.The content of agomelatine was assigned as 99.9%,which was basically consistent with the results of nuclear magnetic resonance quantitative method,perchloric acid non-aqueous titration and DSC.Conclusion:The first batch of national reference standard of agomelatine can be applied for the identification and content determination of agomelatine and its related preparations.
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