Quality Studies For Maropitant Citrate

Maropitant citrate is a type 1 neurokinin（NK1）receptor antagonist,which acts on the central nervous system of the user by inhibiting substance P and plays an antiemetic role.Based on the study of residual solvents and the determination of related substances and assay of maropitant citrate,this paper established methods to better control the quality of maropitant citrate.In this paper,the detection methods were as follows:1)Residual solvents:A method for the determination of toluene,dichloromethane,tetrahydrofuran,acetone and methyl tert-butyl ether in maropitant citrate by gas chromatography was established.DA-624（60 m×0.25 mm,1.4μm）column was used,and detected by FID detector.The carrier gas was nitrogen.The temperature programming was used.The temperature of injector was 150℃,and the detector temperature was 250℃.The split ratio was used at 10:1.2)Related substances:The method adopted the CAPCELL PAK C18 MG II（4.6mm×250 mm,5μm）chromatographic column with 0.01 mol/L dipotassium hydrogen phosphate solution（pH7.5 with phosphoric acid）—acetonitrile as mobile phase,Gradient elution with the flow rate 1.0 mL·min^-1,column temperature was 40℃,injection volume was 20μL,and detection wavelength was 222 nm.3)Assay:The column was CAPCELL PAK C18 MG II（4.6 mm×250 mm,5μm）,and mobile phase was 0.01 mol/L dipotassium hydrogen phosphate solution（pH 7.5 with phosphoric acid）:acetonitrile=20:80.The detection wavelength was 222 nm,the flow rate was 1.0 mL·min^-1,the column temperature was 40℃,and the injection volume was20μL.In this article,The quality of maropitant citrate was established from four aspects:characters,identifications,tests and assay.According to the results of sample detection and the preliminary stability data,the quality of the product meets the requirements.