Chalgeri A, Tan H S
Division of Pharmaceutics and Drug Delivery Systems, College of Pharmacy, University of Cincinnati Medical Center, OH 45267.
J Pharm Biomed Anal. 1993 Apr-May;11(4-5):353-9. doi: 10.1016/0731-7085(93)80028-y.
The development of a simple HPLC procedure is described for the analysis of citrate in pharmaceutical formulations using the technique of indirect photometric chromatography. A novel mobile phase, using dual eluent species, was developed for rapid elution of citrate. The developed method was found to be linear over the range studied (1-12 micrograms of citrate injected), showed good per cent recoveries (+/- RSD) of 97.5 +/- 3.05% from a generalized matrix solution, and includes very simple sample preparation steps for analysis of commercial products. This method is quite specific for tricarboxylic acids as most other ions are not retained by the column using the developed mobile phase. The resolution of the method is also good as indicated by a baseline resolution (Rs = 1.5) obtained for citrate and tricarballylate, two structurally similar tricarboxylic acids. It is proposed that the developed method be evaluated as an alternative to the tedious procedures employed by the USP for assay of total citrate in some of its monographs.
描述了一种简单的高效液相色谱(HPLC)方法的开发,该方法采用间接光度色谱技术分析药物制剂中的柠檬酸盐。开发了一种使用双洗脱剂的新型流动相,用于柠檬酸盐的快速洗脱。在所研究的范围内(进样1 - 12微克柠檬酸盐),所开发的方法呈线性,从通用基质溶液中回收率良好(±相对标准偏差),为97.5 ± 3.05%,并且对于商业产品分析包括非常简单的样品制备步骤。该方法对三羧酸具有相当的特异性,因为使用所开发的流动相时,大多数其他离子不会被色谱柱保留。正如柠檬酸盐和异柠檬酸(两种结构相似的三羧酸)获得的基线分离度(Rs = 1.5)所示,该方法的分离度也很好。建议将所开发的方法作为美国药典(USP)在其一些专论中用于测定总柠檬酸盐的繁琐程序的替代方法进行评估。