摘要
目的通过改进药典标准中尼莫地平片溶出度方法及测定方法,以达到区分不同厂家尼莫地平片质量差异的目的。方法建立高效液相色谱法(HPLC)测定尼莫地平片的体外溶出度,以尼莫地平溶解度、稳定性和区分能力为评价指标,筛选溶出介质。结果与结论采用HPLC法,以Kromasil KR100-5C18(4.6mm×150mm,5μm)为色谱柱,以乙腈-四氢呋喃-水(1∶1∶3)为流动相,流速1.0mL·min-1,柱温40℃,检测波长235nm,以pH4.5醋酸盐缓冲溶液(含0.1%十二烷基硫酸钠)为溶出介质,可良好区分不同厂家尼莫地平片溶出曲线的差异。
Objective To distinguish the quality difference of nimodipine tablets by improving the dissolution test method and the assay method described in the pharmacopeial standard.Methods An HPLC method was established to determinate in vitro dissolution of nimodipine,and the appropriate dissolution medium was selected according to indexes of nimodipine solubility,stability and distinguishing ability.Results and Conclusion Kromasil KR100-5C18（4.6 mm×150 mm,5μm）was chosen as the column,acetonitrile-tetrahydrofuran-water（1∶1∶3）was used as the mobile phase.The flow rate,the column temperature and the detection wavelength were respectively set at 1.0 mL·min^-1,40 ℃ and 235 nm.pH4.5acetate buffer solution containing 0.1% sodium dodecyl sulfate was chosen as the appropriate dissolution medium.This HPLC method could well distinguish dissolution profiles of nimodipine tablets produced by different manufacturers.
出处
《中国药事》
CAS
2014年第11期1227-1230,共4页
Chinese Pharmaceutical Affairs
基金
上海市科学技术委员会科研计划项目课题--尼莫地平的质量标准研究(编号10dz1900402)
关键词
尼莫地平片
溶出度
方法改进
nimodipine tablets
dissolution
method improvement
