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

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,5μm）;流动相为甲醇-0.5%冰乙酸溶液（60∶40）;流速为0.8 m L·min^-1;检测波长为338 nm;柱温为30℃。结果吡罗昔康在0.016~158.7μg·m L^-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。

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 m L·min^-1. The detection wavelength was 338 nm and the column temperature was 30 ℃. RESULTS The linear range was 0.016-158.7 μg·m L^-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.