高效液相色谱法测定奈韦拉平片有关物质及其含量

Determination of Related Substance in Nevirapine Tablets by High Performance Liquid Chromatography

目的采用高效液相色谱仪建立奈韦拉平片中有关物质及其含量的测定方法,为其质量控制提供参考。方法采用ODS-C18柱(250mm×4.6mm,5μm);流动相:乙腈-0.025mol/L磷酸二氢铵溶液(20∶80);流速:1.0ml/min;检测波长:220nm。结果线性范围为5～100μg/ml(r=1.000 0)检测限为0.9ng,样品在24h内稳定性、精密度良好,RSD=0.2%,平均回收率为100.36%。结论所建立的高效液相色谱法简便、快速、准确、专属性高,适用于奈韦拉平片中有关物质及其含量的测定。

Objective To establish a method for determining the content of related substance in nevirapine tablets by high performance liquid chromatography （HPLC） and to provide a reference for the quality control of nevirapine tablets. Methods HPLC was performed on ODS C18 column （250 mm X 4.6 mm, 5 μm） with a mobile phase of acetonitrile-0. 025 mol/L ammonium dihydrogen phosphate （20： 80） at a flow rate of 1.0 ml/min and a detection wavelength of 220 nm. Results The content of related substance showed a good linear relationship with peak area in the range of 5-100 #g/ml （r=l. 000）; the detection limit was 0.9 ng. The sample had high stability within 24 h, and the instrument had high precision. The relative standard deviation was 0.2~. The average recovery rate was 100.36%. Conclusion This HPLC method can be used for the determination of related substance in nevirap ine tablets because of its simplicity, efficiency, accuracy, and high specificity.