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目的建立高效液相色谱法测定尼美舒利的含量及有关物质。方法色谱柱为Hypersil BDSC18柱(250mm×4.6mm,5μm),以0.1%三氟乙酸-乙腈(60∶40)为流动相,流速1.0ml/min,检测波长分别为298nm(含量测定)与230nm(有关物质检查),柱温35℃。结果尼美舒利在10～200μg/ml浓度范围内,线性关系良好(r=0.9999);杂质邻氨基二苯醚、2-苯氧甲烷磺酰苯胺、邻硝基二苯醚均在0.1～10.0μg/ml浓度范围内,线性关系良好(r=0.9999),最低检测限分别为0.8、0.9、0.5ng。结论本方法简便、快速,结果准确、可靠,重现性较好,可用于尼美舒利的有关物质检查和含量测定。
Objective To establish a HPLC method for the determination of nimesulide and its related substances. Methods The column was Hypersil BDSC18 (250 mm × 4.6 mm, 5 μm) with a mobile phase of 0.1% trifluoroacetic acid-acetonitrile (60:40) at a flow rate of 1.0 ml / min. The detection wavelength was set at 298 nm (Related substances check), column temperature 35 ℃. Results Nimesulide showed a good linearity (r = 0.9999) within the concentration range of 10 ~ 200μg / ml. The content of o-aminodiphenylether, 2-phenoxymethanesulfonanilide and o- In the concentration range of 10.0μg / ml, the linearity was good (r = 0.9999), the minimum detection limits were 0.8, 0.9, 0.5ng respectively. Conclusion The method is simple, rapid, accurate, reliable and reproducible. It can be used for the related substances examination and determination of nimesulide.