盐酸乐卡地平片有关物质HPLC检查方法研究

目的:建立盐酸乐卡地平片有关物质检查方法,为进一步控制盐酸乐卡地平片质量发展提供参考依据,为高血压患者的安全用药提供有效保障。方法:采用高效液相色谱法:色谱柱:依利特300A-ODS(5μm、4.6x200mm);流动相:乙腈-0.01moL/L乙酸铵溶液-三乙胺(650:350:1)用乙酸调节pH值至6.0];流速为1mL/min;柱温25℃;检测波长240nm。结果:本方法可检出盐酸乐卡地平片中已知杂质,并能检出高温、光照、强酸、强碱、氧化破坏试验所产生的降解产物,有关物质检查数据表明:本品样品及上市品的有关物质均小于0.75%,单个最大杂质均小0.3%。结论:本法快速、灵敏、重现性好,可用于盐酸乐卡地平片有关物质的检查。

Detection of impurities Lercanidipine

Objective Establish lercanidipine hydrochloride radiographs related substances to check method,in order to further control quality of lercanidipine hydrochloride,and provides the reference for the development of the safety of patients with hypertension,provide effective safeguard medication.Methods A high performance liquid chromatographic method: Column: Elite 300A-ODS(5μm,4.6×200mm);mobile phase:acetonitrile-0.01moL/L ammonium acetate solution-three procedures(650:350:1) use acetic adjusting the pH and 6.0],1mL/min velocity,column temperature 25℃,240nm detected wavelength.Results Various test result by the above the chromatographic conditions specificity is good,accord with this product relevant material inspection,at the request of the relevant material inspection after data indicate that this product samples,and the relevant materials listed product are less than a single biggest impurities,0.75% are less than 0.3 percent.Conclusion This method is article quickly,agility,reproducible and can be used for joy of lercanidipine hydrochloride related substances check.