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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。
OBJECTIVE: To establish a method for the determination of lercanidipine hydrochloride tablets, and to provide a reference for further controlling the quality of levodipine hydrochloride tablets, so as to provide an effective guarantee for the safe medication of hypertensive patients. Methods: High performance liquid chromatography (HPLC) was used. Column: Elite 300A-ODS (5μm, 4.6 × 200mm); mobile phase: acetonitrile-0.01moL / L ammonium acetate solution-triethylamine Adjust the pH to 6.0]; flow rate of 1mL / min; column temperature 25 ℃; detection wavelength of 240nm. Results: The method can detect the known impurities of lercanidipine hydrochloride tablets, and can detect the degradation products produced by high temperature, light, strong acid, alkali and oxidative destruction test. The data of the related substances show that the samples are listed and listed The relevant substances are less than 0.75%, the largest single impurity is 0.3%. Conclusion: This method is rapid, sensitive and reproducible. It can be used to examine the related substances of lercanidipine hydrochloride tablets.