摘要

反相液相色谱法快速测定奈韦拉平的稳定性

作者(年代):P.Raghuram, I.V.Soma Raju, J.Sriramulu

建立了一种简便、灵敏的等密度RR-LC定量测定HIV - Aids原料药中奈韦拉平相关化合物的方法。该方法同样适用于该试剂的测定。采用C18固定相和简单的流动相组合，以梯度方式进行高效色谱分离，采用220 nm紫外检测，流速为2.0 mL min-1。在所建立的RRLC方法中，奈韦拉平与其两种潜在杂质的分离度均大于4.0。回归分析表明，奈韦拉平和itÂ两种杂质的r值均大于0.999。在0.24mg mL-1的检测浓度下，以10µL的注射体积检测奈韦拉平的两种杂质，检测浓度为0.01%。两种杂质及奈韦拉平的日间精密度值均在2.0%RSD以内。该方法对奈韦拉平两种杂质(99.0 ~ 102.5%)的回收率一致。试验溶液在稀释液中稳定48小时。药物经受酸水解和还原的应激条件。湿度，光解和热降解。 Considerable degradation was found to occur in acid hydrolysis stress conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5 %. The developed RR-LC method was validated with respect to linearity, accuracy, precision and robustness.