Cox D C, Kirchhoefer R D
J Assoc Off Anal Chem. 1979 May;62(3):552-5.
The determination of chlorpheniramine maleate and brompheniramine maleate in tablets, capsules, injections, and elixirs has been automated. The active ingredient is dissolved in dilute HCl. The dilute acid solution is sampled, made basic with dilute NaOH, and extracted with isooctane. The isooctane phase is resampled and the drug is re-extracted into dilute HCl. The absorbance of the acidic aqueous layer is monitored at 265 nm. The method is an automated version of the general USP XIX assay for salts of organic nitrogenous bases. The results from the semiautomated procedure agree well with the USP XIX and NF XIV official methods. Recoveries were 100% from an authentic tablet material. The system is linear from 0 to 300% of declared potency. The procedure is free from common excipient and dye interferences. Precision data are included for both the automated and official methods.
已实现对片剂、胶囊剂、注射剂和酏剂中马来酸氯苯那敏和马来酸溴苯那敏的自动化测定。活性成分溶于稀盐酸中。对稀酸溶液进行取样，用稀氢氧化钠调至碱性，并用异辛烷萃取。对异辛烷相再次取样，将药物重新萃取到稀盐酸中。在265nm处监测酸性水层的吸光度。该方法是美国药典第十九版中有机含氮碱盐通用测定法的自动化版本。半自动程序的结果与美国药典第十九版和国家处方集第十四版的官方方法吻合良好。从真实片剂材料中的回收率为100%。该系统在标示效价的0%至300%范围内呈线性。该程序不受常见辅料和染料干扰。文中包含了自动化方法和官方方法的精密度数据。
