论文部分内容阅读
目的:建立尼美舒利颗粒有关物质的HPLC测定方法。方法:采用Agilent HC-C_(18)(250 mm×4.6 mm,5μm)色谱柱;流动相:乙睛-0.01mol·L~(-1)磷酸二氢铵溶液(氨水调pH至7.0)(40:60);检测波长:230 nm;流速1.0 ml·min~(-1);柱温:30℃;进样量:20μl。结果:尼美舒利在0.10-0.30 mg·ml~(-1)(r=0.999 9)浓度范围内线性关系良好,各杂质峰与主峰分离度均大于2.0,检测限为0.3 ng,定量限为1.0 ng。结论:本方法专属性强淮确度高,重现性良好,可用于尼美舒利颗粒的质量控制。
Objective: To establish a method for the determination of nimesulide particles by HPLC. METHODS: Agilent HC-C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-0.01mol·L -1 ammonium dihydrogen phosphate solution 40:60); detection wavelength: 230 nm; flow rate 1.0 ml · min -1; column temperature: 30 ℃; injection volume: 20 μl. Results: Nimesulide showed a good linearity in the concentration range of 0.10-0.30 mg · ml -1 (r = 0.999 9) with the resolution of more than 2.0 and the detection limit of 0.3 ng. The limits of quantitation 1.0 ng. Conclusion: The method is characterized by high specificity and good reproducibility and can be used for the quality control of nimesulide granules.