RP-HPLC法测定盐酸吡格列酮含量及有关物质的方法学研究

Research on Determination of the Content and the Related Substances of Pioglitazone Hydrochloride by RP-HPLC

目的 :采用反相高效液相色谱法测定盐酸吡格列酮的含量及其有关物质。方法 :采用ODSC18色谱柱 (4 6mm× 2 5 0mm ,填料 :Kromasil,粒度 :5 μm) ,以乙腈 -水 -乙酸 (45∶5 5∶0 3,用氨水调节体系的pH为 5 5±0 0 5 )为流动相 ,流速 1 2mL·min-1,紫外检测器于 2 6 9nm测定。结果 :反相HPLC法测定的线性范围为 0 0 1～1 0mg·mL-1,相关系数r=0 9999;最低检测限 0 2ng ;样品溶液在 10d内稳定 ;日内精密度 (RSD <1 0 % )和日间精密度 (RSD <2 0 % )良好。结论 :采用反相HPLC法测定盐酸吡格列酮的含量及其有关物质方法简便 ,结果准确。

Objective:To determine the content and the related substances of pioglitazone by RP-HPLC. Methods:The column:ODS C 18 column(4 6 mm×250 mm,filler:Kromasil, size:5 μm);The mobile phase:acetonitrile-water-acetic acid (45∶55∶0 3,to make up the pH 5 50±0 05 with ammonia);The flow rate:1 2 mL·min -1 ;The detective wave length:269 nm.Results:The linear range of the determination by RP-HPLC is 0 01～1 0 mg·mL -1 ;The correlation coefficient is 0 999 9;The least detective range is 0 2 ng;The sample solution is stable within 10 days;The precision in a day (RSD<1 0%)and during the days (RSD<2 0%)are good.Conclusions:The method to determine the content and the related substances of pioglitazone by RP-HPLC is easy to operate and the results of the determination is accurate.