摘要
目的:建立尼莫地平及制剂中光降解产物含量的测定方法。方法:采用反相高效液相色谱法,Shiseido CAPCELL PAK C18(250mm×4.6mm,5μm)色谱柱,流动相为甲醇-乙腈-水(35:38:27),流速为1.0ml/min,检测波长为235nm。结果:尼莫地平和杂质A在0.1—4μg/ml的浓度范围内,均与其峰面积呈良好线性(尼莫地平:r=0.999996,n=6;杂质A:r=0.999995,n=6)。精密度试验尼莫地平的RSD为0.1%(n=5),杂质A的RSD为1.2%(n=5),尼莫地平的最低检测限为0.02ng,杂质A的定量限为0.2ng。结论:本方法简便、结果准确,能控制尼莫地平及其制剂的质量。
Objective : To establish HPLC method for determining the light - introduced degradation products in nimodipine and its preparations. Method: Shiseido CAPCELL PAK C18 ( 250 mm × 4.6 mm,5 μm ) column was applied as stationary phase and methanol- acetonitrile- water( 35: 38: 27) acted as mobile phase,the flow rate of which was 1.0 ml/min. The detection wavelength was at 235 nm. Results : The assay exhibited a good linearity over the concentration range of 0.1 - 4 μg/ml ( nimodipine : r = 0. 999 996, n = 6 ; impurity A : r = 0. 999 995, n = 6 ). RSD for nimodipine was 0.1% ( n = 5 ), and 1.2% ( n = 5 ) for impurity A. The limit of detection ( LOD )of nimodipine was 0.02 ng, and the limit of quantitativity ( LOQ ) of impurity A was 0.2 ng. Conclusion : The method established in this paper is simple, accurate, and has provided the good guarantee for quality control of nimodipine and its preparations.
出处
《天津药学》
2009年第2期3-6,共4页
Tianjin Pharmacy