高效液相色谱法测定复方磷酸哌喹片的有关物质  

Determination of Related Substances of Compound Piperaquine Phosphate Tablets by HPLC

作　　者：熊苗苗[1] 汪秋兰[1] 施春阳[1] 方建国[1] 谢委[1] 万进[1] 

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030

出　　处：《医药导报》2013年第1期75-77,共3页Herald of Medicine

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.

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 

分 类 号：R978.6[医药卫生—药品] R927.2[医药卫生—药学]