Study On The Quality Standard Of Esomeprazole Sodium Raw Materials

Esomeprazole sodium is the sodium salt of the S-isomer of omeprazole.It is the first single-isomer proton pump inhibitor(PPI)in the word,mainly to treat diseases associated with gastric acid.With the improvement of synthetic technology and the progress of industrialization,the synthesis process route of Esomeprazole sodium is improved,and the quality of the API is also enhancing.But the corresponding detection method is not perfected in time.In order to better serve the pharmaceutical companies and facilitate the smooth progress of industrialization,the quality standards of its bulk drug need to be established.In the paper,we studied the bulk drug of esomeprazole sodium in the residual organic solvents,the type of related substances and esomeprazole sodium drug content of the detection.The quality standard of esomeprazole sodium raw materials(draft)has been drafted,which provides an experimental basis for quality supervision in the process of industrialization of API in China.Objective:To establish the quality standard of esomeprazole sodium raw materials,the determination methods of the contents of residual organic solvents,related substances and esomeprazole sodium in its bulk drug were studied.Methods: The determination of residual solvent in the sample of raw material was studied by headspace gas chromatography.The content determination of related substances and esomeprazole sodium were studied by high performance liquid chromatography(HPLC).Results:For the three batches of esomeprazole sodium drug samples,no residual solvent was detected by headspace gas chromatography.The content of related substances was within the limits of the standard by HPLC.Using the established high performance liquid chromatography to detect three batches of samples,the content of esomeprazole sodium was higher than 98.5%.Conclusion : The established analysis method of residual solvent,related substances and esomeprazole sodium content has high precision,good tolerance,etc.And on this basis,the quality standard of esomeprazole sodium raw materials(draft)has been drafted.