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本文报告的方法可将地尔硫与反式地尔硫、七种已知和数种未知化合物相分离。除一种起始中间体其灵敏度约为2％外,其他化合物的最小检测量均小于0.1％。该测定方法的变异系数为0.15％。四批原料药和四批片剂中各有关化合物测得结果均小于0.25％。实验采用Varian Vista 5560型液相色谱仪,于波长240nm处进行紫外检测;Waters μ-Bondapak C_(18)柱(3.9×300mm,id)。流动相
The method reported here separates diltiazem from trans-diltiazem, seven known and unknown compounds. With the exception of a starting intermediate with a sensitivity of about 2%, the minimum detectable levels for all other compounds were less than 0.1%. The coefficient of variation for this assay is 0.15%. Four batches of API and four batches of tablets in the relevant compounds measured results were less than 0.25%. The experiments were performed on a Varian Vista 5560 liquid chromatograph with UV detection at a wavelength of 240 nm. A Waters μ-Bondapak C_ (18) column (3.9 × 300 mm, id) was used. Mobile phase