Brun F, Veuthey J L
Laboratory of Pharmaceutical Analytical Chemistry, University of Geneva, Switzerland.
J Pharm Biomed Anal. 1996 Jun;14(8-10):1251-9. doi: 10.1016/0731-7085(95)01700-3.
The separation of HPLC of basic drugs on silica-based reversed phases remains a major problem because of the interaction between the residual silanol groups of the silica and the amino function of the drug. This paper describes the validation of HPLC methods for the determination of two injectable solutions of basic drugs (two local anaesthetics, chloroprocaine and bupivacaine), with two commercial base-deactivated reversed phases. These columns improve the chromatographic performances without adding a blocking agent to the mobile phase. With a simple aqueous-organic mobile phase, these base-deactivated reversed phases give high theoretical plate numbers (N) and small tailing factors. The optimized methods show good linearity, precision (RSD < 2%) and accuracy (bias < 2% for dosage forms). The limits of detection and quantitation are lower than the maximal accepted limits for impurities. These methods are currently in routine use in stability studies.
由于硅胶残留硅醇基团与碱性药物氨基功能之间的相互作用，在硅胶基反相上通过高效液相色谱法分离碱性药物仍然是一个主要问题。本文描述了采用两种市售的碱钝化反相柱对两种碱性药物（两种局部麻醉剂，氯普鲁卡因和布比卡因）注射剂溶液进行高效液相色谱法测定的方法验证。这些色谱柱在不向流动相中添加封端剂的情况下提高了色谱性能。使用简单的水 - 有机流动相，这些碱钝化反相柱可提供高理论塔板数（N）和小拖尾因子。优化后的方法显示出良好的线性、精密度（RSD <2%）和准确度（剂型偏差<2%）。检测限和定量限低于杂质的最大可接受限度。这些方法目前正在稳定性研究中常规使用。
