UPLC法测定奈韦拉平的含量及有关物质

摘要

Objective:To establish an UPLC method for determination of Nevirapine and related substances. Method:The assay was performed on an Acquity UPLC TSS T3 C18 column (2. 1 mm × 50 mm,1. 8 μm) with the mobile phase of 10 mmol·L-1 ammonium dihydrogen phosphate (pH 5. 0)-acetonitrile (80∶20). The flow rate was 0. 7 mL·min-1 and the detection wavelength was 220 nm. Results:The linear response range of Nevirapine was 0. 16-0. 96 mg·mL-1(r=0. 999, n=6), the average recovery was 99. 6%with RSD of 2. 0%(n=9). Conclusion:The method is rapid,simple, accurate and specific.%目的：：改进奈韦拉平的含量和有关物质测定方法。方法：采用 Acquity UPLC TSS T3 C18(2．1 mm ×50 mm,1．8μm),流动相为10 mmol·L-1磷酸二氢铵溶液(pH 5．0)-乙腈(80∶20),流量为0．7 mL·min-1,检测波长为220 nm。结果：奈韦拉平在0．16~0．96 mg·mL-1的范围内线性关系良好(r=0．999,n=6),平均回收率为99．6%,RSD=2．0%(n=9)。结论：本方法快速、简便、准确,专属性强。