Study On The Quality Standard Of Parecoxib Sodium API

The study of paracoxib sodium can increase the choice of clinical medication,which is of great significance for the development of drugs with low price and high quality.In this paper,with reference to the relevant provisions of the pharmacopoeia and chemical medicine material standards to establish the standardization process of technical guidelines,in character,identification,pH and chloride,sulfate solution,heavy metals,determination of moisture,dry weight loss,microbial limit,related substances and the examination such as residual solvents,and content determination as an index,using the analysis method of GC and HPLC method and other modern preparation technology,the quality standards for Paris yesterday cloth sodium.The main research work of this paper includes:1.To establish an efficient and sensitive analytical method for the development and verification of the related substances of paracoxib sodium raw materials.The verified items include precision,accuracy,specificity,detection limit,quantitative limit,linearity and range,durability,etc.2.Develop and verify the residual solvents of paracoxib sodium raw materials,and establish an efficient and sensitive analytical method.The verified items include precision,accuracy,specificity,detection limit,quantitative limit,linearity and range,durability,etc.3.Based on the development and verification of the content determination method of paricicab sodium,a method of good reproducibility,high accuracy and convenience was established,and the analytical method was established and verified.The verification items include precision(repeatability test.intermediate precision test,sample injection precision),accuracy(recovery rate test),solution stability,linear range,etc.