雷贝拉唑钠有关物质测定时样品溶液稳定性研究

目的:优化雷贝拉唑钠有关物质测定样品溶液溶剂系统,提高样品溶液稳定性,提高有关物质测定结果的准确性。方法:通过析因试验来分析判定抗氧剂用量和溶液pH值对样品溶液稳定性的影响,对样品溶液溶剂系统进行优化。结果:抗氧剂用量和溶液pH值对样品溶液稳定性的影响存在协同作用,其中溶液pH值影响较大;对样品溶剂优化后,稳定时间由原来的0.5 h延长至4 h(在室温20℃~30℃),能满足有关物质准确测定的需求;优化后的溶剂系统并未对有关物质测定方法的专属性造成影响。结论:采用亚硫酸盐溶液(7.56 g亚硫酸钠和1.0 g氢氧化钠溶于1000 mL水中)-乙腈(80∶20)作为溶剂,溶解雷贝拉唑钠,样品溶液的稳定性大大提高,且符合有关物质测定要求。

Stability Study of the Sample Solution Using for the Measurement of Related Substance in Raberprazole Sodium

Objective： To optimize the solvent system of sample solution for the measurement of relatedsubstances in raberprazole sodium in order to increase the stability of sample solution and the accuracy ofmeasurement results. Methods： The influence of antioxygen quantity and solution pH on the solution sta-bility were determined by factorial experiment to optimize the sample solution solvent system. Results： Thedose of antioxygen and the pH of solution had synergistic influence on the stability of sample solution, butthe influence of the pH of solution was greater. After optimization, the stability time prolonged to 4 h from0.5 h （at room temperature of 20℃～30℃） which can guarantee the accurate measurement of related sub-stances. The solvent system after optimization had no interference to the specificity of the measurementmethod. Conclusion： Resolving raberprazole sodium with the sulfite solution （resolving 7.56 g Na2SO3 and1.0 g NaOH in 1000 mL water）- acetonitrile （80：20） can greatly improve the solution stability and meet therequirements of related substances measurement.