HPLC法测定盐酸喹那普利片有关物质

目的: 建立测定盐酸喹那普利片有关物质的HPLC方法。 方法: 采用Agilent 1200型高效液相色谱仪,色谱柱为Agilent XDB C₁₈(250 mm×4.6 mm,5 μm),流动相为甲醇-水-磷酸-二乙胺(60∶ 40∶ 0.13∶ 0.16),流速1.0 mL·min^-1,检测波长215 nm,柱温40 ℃,进样量20 μL。 结果: 盐酸喹那普利和已知杂质喹那普利环合物分别在1.084~32.52 μg·mL^-1和0.521~15.63 μg·mL^-1范围内与峰面积呈良好的线性关系;喹那普利环合物、各破坏性分解产物能和主峰分离,测得盐酸喹那普利最小检测限为2.134 ng,喹那普利环合物最小检测限为2.156 ng。 结论: 本方法准确、灵敏、可靠,专属性强,可用于盐酸喹那普利片的质量控制。

Objective: To establish an HPLC method for determination of related substances in quinapril hydrochloride tablets. Methods: The HPLC method was performed on an Agilent 1200 liquid chromatography.Agilent XDB C₁₈(250 mm×4.6 mm,5 μm) was adopted with the mobile phase of methanol-water-phosphoric acid-diethylamine(60∶ 40∶ 0.13∶ 0.16).The flow rate was 1.0 mL·min^-1 and the detection wavelength was set at 215 nm.The column temperature was set at 40 ℃ and the injection volume was 20 μL. Results: The linear ranges of quinapril hydrochloride and quinapril diketopiperazine were 1.084-32.52 μg·mL^-1,0.5210-15.63μg·mL^-1,respectively.The degradation substances and quinapril diketopiperazine could be separated from main peak.The lowest detectable limits of quinapril hydrochloride and quinapril diketopiperazine were 2.134 ng,2.156 ng,respectively. Conclusion: The method is simple,specific,and suitable for control of quinapril hydrochloride tablets.