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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0.016~158.7?g·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 HPLC determination of piroxicam injection and its related substances. Methods The chromatographic column was Inertsil ODS-SP (4.6 mm × 250 mm, 5 μm). The mobile phase was methanol-0.5% glacial acetic acid (60:40) at a flow rate of 0.8 m L · min -1. The detection wavelength was 338 nm. The column temperature was 30 ° C. Results There was a good linear relationship between piroxicam and 0.016-158.7 μg · m L · 1, r = 0.999 8 (n = 6). The average recovery of the three high, middle and low concentrations was 99.13%, and the RSD of the instrument was 0.19%. Conclusion The method is convenient, simple and accurate, suitable for the determination of piroxicam injection content and related substances.