HPLC测定吡罗昔康注射液含量及有关物质

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。

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

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.