摘要
目的建立高效液相色谱法检查复方磷酸哌喹片中有关物质。方法采用Waters Atlantis C18(250 mm×4.6 mm,5μm),以10 mmol.L-1庚烷磺酸钠与25 mmol.L-1磷酸二氢钾等量混合溶液-乙腈-甲醇(53∶16∶31,用磷酸调节pH至2.5)为流动相,流速0.9 mL.min-1,检测波长:348 nm,柱温:40℃。结果磷酸哌喹、磺胺多辛两主成分峰与各杂质峰均能良好分离,磷酸哌喹最低检测限为0.41 ng,磺胺多辛最低检测限为108.24 ng。结论该方法简便、快速,结果准确可靠,适用于复方磷酸哌喹片中有关物质的检查。
Objective To establish a HPLC method for determination of related substances of compound piperaquine phosphate tablets. Methods The column was Waters Atlantis C18（250 mm×4.6 mm, 5 μm）. The mobile phase was 10 mmol . L^-1 sodium 1-heptanesulfonate and 25 mmol. L^-1 potassium dihydrogen phosphate equal mixtureacetonitrile-methanol（53 ： 16 ： 31, adjusted to pH 2.5 with phosphoric acid）. The flow rate was set at 0.9 mL · min^-1 The detective wavelength was at 348 nm and the column temperature was at 40 ℃. Results The two main chromatogram peaks were successfully seperated from other impurity ones;the limit of detection for piperaquine phosphate was 0.41 ng, while for sulfadoxine was 108.24 ng. Conclusion This method is simple, rapid, accurate and reliable, which is suitable for determination of the related substances of compound piperaquine phosphate tablets.
出处
《医药导报》
CAS
北大核心
2013年第1期75-77,共3页
Herald of Medicine
关键词
磷酸哌喹
复方
哌喹
磷酸
磺胺多辛
有关物质
色谱法
高效液相
Piperaquine phosphate, compound
Piperaquine phosphate
Sulfadoxine
Related substances
HPLC
