Suzuki H, Akimoto K, Nakagawa H, Sugimoto I
Pharmaceuticals Research Center, Kanebo, Ltd., Osaka, Japan.
J Pharm Sci. 1989 Jan;78(1):62-5. doi: 10.1002/jps.2600780116.
A simple assay procedure for the quantitation of trazodone hydrochloride in tablets, without prior separation, has been developed using a trazodone-selective electrode. The electrode was based on a trazodone:tetrakis(p-chlorophenyl)borate ion-pair complex, dioctyl phthalate, and polyvinyl chloride matrix that were mounted on a PTFE membrane. The electrode showed a near-Nernstian response in the range of 10(-2) to 5 x 10(-6) M trazodone over the pH range of 2.5 to 5.0, with a cationic slope of 58 mV/concentration decade. The durability of the electrode and the reproducibility of the performance among the electrodes were sufficient. The electrode was used for the determination of the pKa value of trazodone. The selectivity of the electrode to a number of interferences was investigated. Many inorganic cations (alkali and alkaline earth metals) and pharmaceutical excipients did not interfere, but some organic ammonium compounds interfered according to their extractability. Determination of 10 to 3000 micrograms/mL of trazodone hydrochloride in aqueous solution showed an average recovery of 100.6% (mean standard deviation 0.4%) by direct potentiometry. This assay was applied to determine trazodone hydrochloride in tablets and the results compared favorably with those obtained by high-performance liquid chromatography.
已开发出一种使用曲唑酮选择性电极对片剂中盐酸曲唑酮进行定量的简单分析程序，无需事先分离。该电极基于曲唑酮：四（对氯苯基）硼酸离子对络合物、邻苯二甲酸二辛酯和聚氯乙烯基质，它们被安装在聚四氟乙烯膜上。在2.5至5.0的pH范围内，该电极在10（-2）至5×10（-6）M曲唑酮范围内呈现近能斯特响应，阳离子斜率为58 mV/浓度 decade。电极的耐用性以及电极之间性能的重现性足够。该电极用于测定曲唑酮的pKa值。研究了电极对多种干扰物的选择性。许多无机阳离子（碱金属和碱土金属）和药用辅料不产生干扰，但一些有机铵化合物根据其可萃取性产生干扰。通过直接电位法测定水溶液中10至3000微克/毫升的盐酸曲唑酮，平均回收率为100.6%（平均标准偏差0.4%）。该分析方法应用于测定片剂中的盐酸曲唑酮，结果与高效液相色谱法获得的结果相比具有优势。
