RP-HPLC测定盐酸奈必洛尔含量和有关物质

目的建立反相高效液相色谱法测定盐酸奈必洛尔含量和有关物质。方法采用的色谱柱为ODS色谱柱(250 mm×4.6 mm,5μm);以甲醇为溶剂,进样浓度:0.5 g.L-1,0.05 mol.L-1的磷酸盐缓冲液(2%三乙胺,pH=3.5)∶乙腈∶甲醇=200∶115∶40为流动相;检测波长为280 nm。结果盐酸奈必洛尔峰与杂质峰分离良好,盐酸奈必洛尔浓度在31.71～158.55 mg.L-1与峰面积呈良好的线性关系(r=0.999 7),最低检检测限为5 ng。方法精密度RSD为0.35%。结论采用反相高效液相色谱法测定盐酸奈必洛尔含量及其有关物质方法快速简便,结果准确。也可用于该品制剂中有关物质和含量的测定。

RP-HPLC determination of nebivolol hydrochloride and its related substances

Objective To establish an RP-HPLC method for the determination of content of nebivolol hydrochloride and its related substances in raw material.Methods An ODS column（250 mm×4.6 mm,5 μm） was used with the mobile phase of 0.05 mol·L-1NaH2PO4 buffer solution（6.8 g potassium dihydrogen phosphate,and add water to 1 000 ml dissolving,and 2 ml triethylamine,adjusted pH to 3.5 with phosphoric acid）-acetonitrile-methanol（200∶ 115∶ 40） at a flow rate of 1.0 ml·min-1 and the detection wavelength of 280 nm.Results The nebivolol hydrochloride and the related substances could be base line separated.The calibration curve was linear in the range of 31.71~158.55 mg·L-1 with r = 0.999 7.The detection limit was 5 ng.The precision（RSD） was 0.35%.Conclusion The method is simple,accurate and rapid to operate and the results of the determination can be used for the quality control of nebivolol hydrochloride.