HPLC测定吡罗昔康注射液含量及有关物质

Determination of the Content and the Related Substances of Piroxicam Injection by HPLC

摘要: 目的建立高效液相色谱法测定吡罗昔康注射液含量及有关物质。方法色谱柱为Inertsil ODS-SP(4.6 mm×250 mm，5 μm)；流动相为甲醇-0.5%冰乙酸溶液(60∶40)；流速为0.8 mL·min^-1；检测波长为338 nm；柱温为30 ℃。结果吡罗昔康在0.016~158.7 mg·mL^-1内呈良好线性关系，r=0.999 8(n=6)。高、中、低3个浓度总的平均回收率为99.13%，仪器精密度RSD为0.19%。结论本方法方便、简单、准确，适于吡罗昔康注射液含量及有关物质的测定。

Abstract: OBJECTIVE To establish an HPLC method for determination of the content and the related substances of Piroxicam injection. METHODS Inertsil ODS-SP(4.6 mm×250 mm, 5 μm) column was adopted with methanol-5% glacial acetic acid (60∶40) as the mobile phase at the flow rate of 0.8 mL·min^-1. The detection wavelength was 338 nm and the column temperature was 30 ℃. RESULTS The linear range was 0.016-158.7 μg·mL^-1, r=0.999 8(n=6); the average recovery was 99.13%, RSD was 0.19%. CONCLUSION The method is simple, accurate, sensitive and reliable for determination of Piroxicam injection.