Kril M B, Burke K A, DiNunzio J E, Gadde R R
Bristol-Myers Squibb Co., Pharmaceutical Research Institute, Buffalo, NY 14213.
J Chromatogr. 1990 Nov 28;522:227-34. doi: 10.1016/0021-9673(90)85192-x.
A stability indicating reversed-phase high-performance liquid chromatographic method has been developed to quantify tretinoin (all-trans-retinoic acid) in cream formulations. Tretinoin cream samples were dissolved directly in tetrahydrofuran and diluted for injection. Separation was accomplished on a 15 cm Nova-Pak C18 column using a tetrahydrofuran-phosphate buffer solvent system (42:58, v/v) and 1.0 ml/min flow-rate. The method is able to separate tretinoin from its degradation products formed under stressing conditions. Excellent precision and accuracy were found for the assay of tretinoin in the cream formulations.
已开发出一种稳定性指示反相高效液相色谱法，用于定量乳膏制剂中的维甲酸（全反式维甲酸）。维甲酸乳膏样品直接溶于四氢呋喃中并稀释后进样。在15 cm的Nova-Pak C18柱上，使用四氢呋喃-磷酸盐缓冲溶剂系统（42:58，v/v）和1.0 ml/min的流速进行分离。该方法能够将维甲酸与其在强制条件下形成的降解产物分离。在乳膏制剂中维甲酸的含量测定中发现了极佳的精密度和准确度。
