高效液相色谱法测定萘哌地尔片有关物质

摘要

目的 建立高效液相色谱法测定萘哌地尔片有关物质的方法.方法 采用Waters C18色谱柱(150 mm×4.6 mm,5 μm);以乙腈-甲醇-0.02 mol·L-1乙酸钠缓冲液(40:30:30)为流动相;检测波长:283nm;流速:1 ml·min-1,柱温:30℃,进样量:10μl.结果在建立的色谱条件下,萘哌地尔与杂质能完全分离;杂质对照品α-萘酚在0.30~1.80 mg·L-1浓度范围内线性关系良好(r＝0.999 4),高、中、低3个浓度的平均回收率分别为98.75%、103.55%、100.02%,RSD分别为0.2%、0.4%、2.4%.结论该法操作简便,结果准确,灵敏度高,专属性强,可用于萘哌地尔片质量控制.%Aim To establish a methods for the determination of related substances of naipaidier tablets by HPLC.Methods The HPLC column was Waters C18.The mobile phase was acetonitrile-methanol 0.02 mol.L-1 sodium acetate(40:30:30)and the flow rate was 1.0 ml·min-1.The injection volume was 10 μl and the temperature of column is 30℃.Results Under the described chromatographic con-dition.Naipaidier was completely separated from its impurities.Α-naphthol was in good linearity within the range from 0.30 to 1.80 mg·L-1(r=0.999 4).The mean recovery of three concentration were 98.75%(RSD=0.2%),103.55%(RSD=0.4%)and 100.02%(RSD=2.4%).Conclusions The method is simple and accurate.Specific and sensitive and can be used for quality control of naipaidier tablets.