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目的:建立高效液相色谱法测定溴芬酸钠含量和有关物质。方法:采用十八烷基硅烷键合硅胶为填充剂(150mm×4.6mm,5μm),0.025mol·L-1磷酸二氢钠溶液(含0.1%三乙胺,用磷酸调节pH至4.0)-乙腈(60∶40)为流动相,流速为1.0mL·min-1,检测波长为270nm。结果:溴芬酸钠与有关物质分离良好,线性范围为48.6～486.0μg·mL-1(r=0.9997),最低检出量为0.5ng。方法精密度(RSD)为0.83%。结论:采用反相高效液相色谱法测定溴芬酸钠含量及其有关物质方法快速简便,结果准确。也可用于本品制剂中有关物质和含量的测定。
Objective: To establish a method for the determination of sodium bromfenac and related substances by high performance liquid chromatography. Methods: The octadecylsilane bonded silica gel was used as filler (150mm × 4.6mm, 5μm), 0.025mol·L-1 sodium dihydrogen phosphate solution (containing 0.1% triethylamine and adjusted to pH 4.0 with phosphoric acid) Acetonitrile (60:40) as the mobile phase, the flow rate of 1.0mL · min-1, detection wavelength of 270nm. Results: The separation of bromfenac sodium and related substances was good with a linear range of 48.6 ~ 486.0 μg · mL-1 (r = 0.9997) and the lowest detection limit was 0.5 ng. The method precision (RSD) was 0.83%. Conclusion: The determination of bromfenac sodium content and its related substances by RP-HPLC method is rapid and simple, and the results are accurate. Can also be used for the determination of the substance and content of the preparation of this product.