摘要
目的建立测定吡罗昔康片有关物质的高效液相色谱法。方法采用C18色谱柱(250mm×4.6mm,5μm),流动相为乙腈-0.05mol·L^(-1)磷酸二氢钾溶液(用磷酸调节pH至3.0)(35∶65),流速1.0m L·min^(-1),检测波长为230nm,柱温为40℃,进样体积为20μL。结果在选定的色谱条件下,主成分与杂质峰之间分离度良好;方法的检测限为0.3μg·m L^(-1);供试品溶液在20h内稳定性良好。结论本方法简单,准确,重现性好,可用于吡罗昔康片的有关物质检查。
OBJECTIVE To establish a HPLC method for the determination of related substances in piroxicam tablets. METHODS The analysis was performed on a C ls column （250mm x 4. 6mm, 51μm）, with acetonitrile- 0. 05mol·L-1potassium dihydrogen phosphate （adjusting pH to 3.0 with phosphoric acid） （35：65） as mobile phase. The flow rate was 1.0mL·min -1 and the detection wavelength was set at 230nm. The column temperature was set at 40℃ and the injection volume was 20μL. RESULTS Related substances were completely separated from the main constituent. The limit of detection was 0. 31μg mL-1. The sample solution was stable within 20h. CONCLUSION The method was simple,accurate with good reproducibility, and can be used in the determi- nation of related substances of piroxicam tablets.
出处
《海峡药学》
2016年第9期55-56,共2页
Strait Pharmaceutical Journal
