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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 %。
Determination of Diltiazem Hydrochloride for Injection and Related Substances by HPL C Method. The mobile phase consisted of Diamonsil C1 8 (150 mm × 4.6 mm, 5 μm) and 0.1 mol / L sodium acetate buffer (p H6.2) -methanol-acetonitrile (5: 6: 6) Is 2 40 nm. The detection limit was 0.2 ng with a linear range of 6-14 μg / ml (r = 0.9998). The RSD was 0.11% with an average recovery of 102.2% and a RSD of 0.52%.