高效液相色谱法测定萘哌地尔片有关物质

Determination of related substances of Naipaidier tablets by HPLC

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,5μm);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 condition,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.