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目的:建立同时测定非诺洛芬钙胶囊含量及有关物质的HPLC方法。方法:采用Agilent1100型高效液相色谱仪,色谱柱为Kromasil C8(4.6mm×250mm,5μm)柱,流动相为乙腈-水-磷酸(50:49.6:0.4),流速1.0mL.min-1,检测波长272nm,柱温30℃,进样量20μL。结果:非诺洛芬的进样浓度在0.1524～152.4μg.mL-1范围内,与峰面积呈良好的线性关系,r=0.9999;A、B两厂家产品的平均回收率(n=9)分别为100.2%和101.0%;热分解产物能从主峰中分离,测得非诺洛芬的最小检出量为0.91ng。结论:本方法准确、灵敏、可靠,专属性强,可用于非诺洛芬钙制剂的质量控制。
Objective: To establish a HPLC method for simultaneous determination of fenoprofen calcium capsules and related substances. Methods: The Agilent 1100 HPLC was used. The column was Kromasil C8 (4.6 mm × 250 mm, 5 μm). The mobile phase was acetonitrile-water-phosphoric acid (50:49. Detection wavelength 272nm, column temperature 30 ℃, injection volume 20μL. Results: The concentration of fenoprofen in the range of 0.1524-152.4 μg.mL-1 showed a good linear relationship with the peak area (r = 0.9999). The average recoveries of fenofibrate (n = 9) Respectively 100.2% and 101.0%; the thermal decomposition products can be separated from the main peak, and the minimum detectable amount of fenoprofen is 0.91ng. Conclusion: The method is accurate, sensitive, reliable and specific. It can be used for the quality control of fenoprofen calcium preparations.