Studies On The Preparation And Quality Of Maropitant Citrate Injection

Maropitant citrate is a neurokinin(NK1)receptor antagonist used to treat and prevent vomiting caused by various clinical causes and motion sickness.In this paper,the preparation of maropitant citrate injection and the quality control of maropitant citrate injection were studied.This article established a method for determining the inclusion rate by ultraviolet spectrophotometry.On the basis of the original prescription,the dosage and sterilization conditions of each excipient were screened to determine the final prescription.The inclusion speed,temperature and time in the craft were screened,and the best craft was determined through the results and actual conditions.The quality of maropitant citrate injection was studied from four aspects of character,identification,test and assay determination,and the following detection methods were established through conditional exploration:1)Related substances,assay and excipient metacresol: The high performance liquid chromatography was used with CAPCELL PAK C18 MGⅡ(250 mm×4.6 mm,5 μm)as column.The mobile phase A was 0.01 mol/L dipotassium hydrogen phosphate solution(pH=7.0)-acetonitrile=70:30 and the mobile phase B was 0.01 mol/L dipotassium hydrogen phosphate solution(pH=7.0)-acetonitrile=30:70.Gradient elution with the flow rate 1.0 m L/min.The detection wavelength was 222 nm.The column temperature was40℃.The injection volume was 20 μL.2)Excipient SBECD: The size exclusion chromatography was used with YMC-PACK Diol-60(300 mm×8.0 mm,5 μm)as column.The mobile phase was 0.1mol/L potassium nitrate solution-methanol=45:55.The flow rate was 2.0 m L/min.The column temperature was 35℃.The temperature of the detector was 35℃ and the injection volume was 15 μL.Methodology validation results showed these methods can be used to detect the maropitant citrate injection.In this paper,the stability test was carried out to investigate the maropitant citrate injection,and it proved that the quality of the imitation drug was equivalent to that of the original prescription.The quality standard of maropitant citrate injection was established,which is scientific and rigorous.