Mazzo D J, Synder P A
Department of Pharmaceutical Research and Development, Merck Sharp & Dohme Research Laboratories, West Point, PA 19486.
J Chromatogr. 1988 Apr 1;438(1):85-92. doi: 10.1016/s0021-9673(00)90235-8.
A novel method for the determination of timolol in pharmaceutical products has been developed and is described. The method employs high-performance liquid chromatography (HPLC) on silica dynamically modified with the cetyltrimethylamomonium cation to quantitate the analyte. The use of this type of reversed-phase HPLC system for timolol determinations results in improved quality of chromatography, especially in terms of peak tailing and peak efficiency, in comparison to chromatography on bonded-phase silica. Column-to-column as well as manufacturer-to-manufacturer reproducibility for this separation on silica columns has been obtained and is better in our hands than that encountered with bonded-phase column packings. The method has been shown to be linear for the compounds studied, comparably accurate and precise to bonded-phase methods and specific for timolol in a variety of pharmaceutical formulations. Under the conditions specified, timolol can be successfully separated from its three potential degradates. Possible explanations of the primary retention mechanisms for the analytes are offered.
已开发并描述了一种测定药品中噻吗洛尔的新方法。该方法采用十六烷基三甲基铵阳离子动态修饰的硅胶上的高效液相色谱（HPLC）来定量分析物。与键合相硅胶色谱相比，使用这种反相HPLC系统测定噻吗洛尔可提高色谱质量，尤其是在峰拖尾和峰效率方面。已获得硅胶柱上这种分离的柱间以及不同制造商间的重现性，且在我们手中比键合相柱填料的重现性更好。该方法已证明在所研究的化合物上呈线性，与键合相方法具有相当的准确性和精密度，并且对多种药物制剂中的噻吗洛尔具有特异性。在规定条件下，噻吗洛尔可成功与其三种潜在降解产物分离。还提供了分析物主要保留机制的可能解释。
