摘要
目的:建立一种高效液相色谱法测定尼群地平片的含量及有关物质的方法。方法:以C18为固定相,甲醇一水(70:30)为流动相,检测波长:237nm。结果:尼群地平片的浓度在20~180μg/ml范围内线性关系良好,回归方程:Y=39128X-66845,r=0.9999精密度试验RSD%=0.9%(n=9),片剂的回收率为100.5%(RSD%=0.6%,n=5)。有关物质可检出2个杂质。结论:本方法测定尼群地平的含量及有关物质,分离效果好,结果准确。
Objective: A HPLC method was established for the determination of nitrendipine tablet and related substances. Methods: Nitrendipine was separated in an C18 column with the mobile phase of methanol-water (70 : 30) and detectd at 237nm. Results:The standard curve was linear in the range of 20-180μg/ml and the correlation coefficient was 0. 9999. The precision of Nitrendipine was good (RSD=0. 9% ,n = 9) and the mean recovery of the tablet was 100. 5% (RSD=0. 6% ,n = 5). Concluson: The affect of separation of the method is good and the result is accurate.
出处
《中国药品标准》
CAS
2004年第2期53-55,共3页
Drug Standards of China