摘要
采用 HPL C法测定注射用盐酸地尔硫的含量及有关物质。色谱柱为 Diamonsil C1 8( 15 0 mm× 4.6 m m,5μm ) ,0 .1m ol/ L醋酸钠缓冲液 ( p H6 .2 ) -甲醇 -乙腈 ( 5∶ 6∶ 6 )为流动相 ,检测波长为 2 40 nm。检测限为 0 .2 ng,线性范围为 6~ 14μg/ ml( r=0 .9998) ,RSD为 0 .11% ,平均回收率为 10 0 .2 % ,RSD为 0 .5 2 %。
A HPLC method for the determination of diltiazem hydrochloride for injection and its related substances was presented. Diamonsil C18 column was used, with mobile phase of 0.1 mol/L sodium acetate buffer solution (pH6.2)-methanol-acetonitrile (5∶6∶6) and at detection wavelength of 236 nm. The detection limit was 0.2 ng. The linear range was 6~14 μg/ml, and average recovery was 100.2% with RSD of 0.52%.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2003年第4期180-182,共3页
Chinese Journal of Pharmaceuticals