目的 研究奈韦拉平齐多拉米双夫定片的药物含量及有关物质的测定方法。方法 色谱柱为Welch Ultimate AQ-C₁₈柱(4.6 mm×250 mm, 5 μm), 0.025 mol·L^-1醋酸铵(调节pH 4.0)-甲醇-乙腈梯度洗脱, 流速1.0 mL·min^-1, 检测波长277 nm, 柱温30 ℃。结果 奈韦拉平、拉米夫定、齐多夫定分别在10.3～310.9、7.9～237.1、14.9～449.6 μg·mL^-1内呈良好线性关系, 相关系数均大于0.999 8, 平均回收率分别为100.6%(RSD 0.4%)、100.0%(RSD 0.7%)和100.2%(RSD 0.6%);各杂质(拉米夫定酸、拉米夫定杂质B、尿嘧啶、胞嘧啶、胸腺嘧啶、奈韦拉平杂质A、奈韦拉平杂质B)之间分离度良好;胞嘧啶、尿嘧啶和胸腺嘧啶分别在76.8～1 152、76.8～1 152、744～14 880 ng·mL^-1内呈良好线性关系, 相关系数均大于0.999 1, 平均回收率分别为101.5%(RSD 4.8%)、102.8%(RSD 4.2%)和101.2%(RSD 1.2%)。结论 该方法快速、简便、准确、重现性好, 可用于奈韦拉平、拉米夫定、齐多夫定含量分析及有关物质研究, 为奈韦拉平齐多拉米双夫定片的质量评价提供研究基础。

OBJECTIVE To develop a method for determination of the contents and related substances in nevirapine zidovudine and lamivudine tablets. METHODS The samples were separated on a Welch Ultimate AQ-C₁₈(4.6 mm×250 mm, 5 μm) column by gradient elution using acetonitrile-methanol-0.025 mol·L^-1 ammonium acetate solution (pH 4.0) as the mobile phase at a flow rate of 1.0 mL·min^-1. The detection wavelength was set at 277 nm, and the column temperature was 30 ℃. RESULTS Nevirapine, lamivudine, and zidovudine had good liner relationship in the range of 10.3-310.9, 7.9-237.1, and 14.9-449.6 μg·mL^-1, respectively. The correlation coefficients were all more than 0.999 8. The average recoveries were 100.6%(RSD 0.4%), 100.0%(RSD 0.7%), and 100.2%(RSD 0.6%), respectively. Complete separation was achieved for the related substances (lamivudine acid, lamivudine related compound B, uracil, cytosine, thymine, nevirapine related compound A, and nevirapine related compound B). Cytosine, uracil, and thymine had good liner relationship in the range of 76.8-1 152, 76.8-1 152, and 744-14 880 ng·mL^-1, respectively. The correlation coefficients were all more than 0.999 1. The average recoveries were 101.5% (RSD 4.8%), 102.8% (RSD 4.2%), and 101.2% (RSD 1.2%), respectively. CONCLUSION The method is rapid, simple, and accurate with good reproducibility. It can be used for the quality control of nevirapine zidovudine and lamivudine tablets.