The Organic Impurities And Stability Study Of Rabeprazole Sodium

Rabeprazole sodium is a new type of proton pump inhibitor capable of treating gastric acid-related diseases.It plays a role in inhibiting gastric acid secretion mainly by inhibiting the activity of H~+/K~+-ATPase in gastric parietal cells.The effect on inhibiting gastric acid has a faster onset,long maintenance time,little individual differences.Our group optimized the producing process of rabeprazole sodium by cooperating with the Hunan RuHong Pharmaceutical Co.Ltd.It is necessary that the methods for quality control should be established in order to make the enterprise produce good products.In this paper,the method for detecting organic impurities had been proposed,and the product stability had been researched.The optimum conditions for the determination of organic impurities in the raw material of rabeprazole sodium were as follows:the mobile phase consisted of phosphate buffer solution(A)and acetonitrile(B),and elution was performed as a gradient elution program.The proportion of A to B(V/V)in the mobile phase was 85 to 15 at the start of each run,ramped to 60 to 40 at 10 min and held until 35 min,then returned to 85 to 15 at 35.01 min and held until 45 min recondition the column.The flow rate was lmL/min.The experimental results show that the known impurities and impurities in the chromatographic conditions and impurities and the main components can be separated from each other,the solvent blank on the determination of each impurity no significant interference,the concentration of each known impurities and peak(Correlation coefficient R>0.990).The relative standard deviations of each group were 1.1%～4.3%,which was in accordance with the requirements of pharmacopoeia.This method is simple and easy to use,and has a high sensitivity and accuracy for the detection of organic impurities in the raw material of rabeprazine sodium.In order to investigate the stability of the raw material of rabeprazole sodium,the influencing factors test(high temperature test,high humidity test,strong light test),accelerated experiment and long-term experiment were carried out by using rabeprazole sodium.The results showed that rabeprazole sodium API would accelerate degradation under high temperature and strong light,and it would be very easy to absorb water under the condition of high humidity.Therefore,rabeprazole sodium raw material should be kept in sealed container and a cool,dry environment.The accelerated and long-term trials indicated the product qualities met the enterprise standards,and the chosen packaging materials and packaging manner was suitable.