反相高效液相色谱法测定佐芬普利钙原料的有关物质

Determination of Related Substances in Zofenopril Calcium by RP-HPLC

目的建立测定佐芬普利钙原料中有关物质的反相高效液相色谱法。方法采用Zorbax Eclipse Plus C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-水-冰醋酸(76∶24∶1)为流动相,检测波长220 nm,柱温40℃,流速1 mL/min。结果佐芬普利钙质量浓度在1.02～6.12μg/mL范围内与峰面积线性关系良好(r=0.999 9),最低检测限为0.204 ng,佐芬普利钙主峰与有关物质峰分离良好。结论所用方法专属性强,适用于佐芬普利钙原料有关物质的测定。

Objective To determine the related substances in the raw material of zofenopril calcium by RP-HPLC method.Methods The Zorbax Eclipse Plus C18 column（250 mm×4.6 mm,5 μm） was used with the mobile phase of methanol-water-glacial acetic acid（76 ∶24 ∶1） at the detection wavelength of 220 nm,the temperature of the column was 40 ℃,the flow rate was 1 mL/min.Results The linearity relation was in the range of 1.02-6.12 μg/mL（r=0.999 9） and the limit of detection（LOD） was 0.204 ng.The related substances could be well separated from the zofenopril.Conclusion This method is simple,accurate,sensitive and suitable for the assay on the related substances in the raw material of zofenopril calcium.