Separation And Analysis Of Three Anti-ulcer Drugs By High Performance Liquid Chromatography

Chromatographyisthemainmethodforquantitativeanalysisof drugs.HPLC is a routine quantitative analysis method for drugs because of its high efficienc y,high sensitivity and reproducibility.In this paper,three anti-ulcer drugs of omeprazole,pantoprazole and rabeprazole were isolated and analyzed by high performance liquid chromatography.The reversed phase high performance liquid chromatography?RP-HPLC?method for the analysis of omeprazole and its two related components and thechiral separation method for enantiomers of pantoprazole and rabezole were established.1.Separation and analysis of omeprazole and its two related components by RP-HPLCThe RP-HPLC method for separation and analysis of omeprazole,2-mercapto-5methoxy-1H-benzimidazole?impurity A?and omeprazole sulfide?impurity B?was established.The mobile phasewas acetonitrile and 15 mmol?L^-1 sodium dihydrogen phosph-ate?pH 7.0?.On the C18 column,gradient elution was utilized and omeprazole and two related components were separated by baseline within 10 min.Methodology validation shows that there is a good linear relationship for omeprazole,impurity A and impurity B between mass concentration and peak area in a certain range?r²?0.9990?,with corresponding detection limits of 15 ng?mL^-1,15 ng?mL^-1and 30 ng?mL^-1?S/N=3?,respectively.Finally,therecoveryrate is98.0%¹01.0%,RSD is 0.61%¹.50%.The method is simple,rapid,accurate and reliable,and is used for the analysis of actual samples to obtain satisfactory results.2.Chiral separation of pantoprazole and rabeprazole enantiomers by liquid chromatography with two chiral selectorPantoprazole and rabeprazole enantiomers were separated and analyzed by ligand exchange liquid chromatography with two chiral selector.The mobile phase was 10 mmol?L^-1 sodium dihydrogen phosphate(containing 0.75 mmol?L^-1 copper?II?,1.125 mmol?L^-1L-histidine,25 mmol?L^-11 HP-?-CD,pH 6.5)and acetonitrile?75:25?.Under the optimized chromatography conditions,the enantiomers of pantoprazole and rabeprazole were 2.1 and2.3,respectively,and the separation time was less than 15 min.This method provides a reference for the development of pantoprazole and rabeprazole chiral drugs and the study of stereoselective pharmacokinetic process.