Kirchhoefer R D
J Assoc Off Anal Chem. 1979 Nov;62(6):1197-201.
A semautomated method for the analysis of chlorpheniramine maleate tablets, which is based on the USP XIX general assay for salts of organic nitrogenous bases, was collaboratively studied by 6 laboratories. Collaborators were supplied with 4 composites from 4 manufacturers. In the method, the active ingredient is dissolved in dilute HCl, 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 solution is measured at 265 nm. The Associate Referee assayed the collaborative samples to compare the semiautomated and USP XIX methods, and found close agreement in the results from the 2 methods. In the collaborative study of the semiautomated method, there was excellent agreement of the results obtained by the collaborators. The coefficients of variation ranged from 0.46 to 2.24%. The method has been adopted as official first action.
一种基于美国药典第十九版有机含氮碱盐通用测定法的马来酸氯苯那敏片半自动分析方法，由6个实验室进行了协同研究。向合作者提供了来自4个制造商的4种混合样品。在该方法中，活性成分溶解于稀盐酸中，取样，用稀氢氧化钠碱化，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处测量酸性水溶液的吸光度。副裁判对协同样品进行了测定，以比较半自动方法和美国药典第十九版方法，发现两种方法的结果非常一致。在半自动方法的协同研究中，合作者获得的结果具有极好的一致性。变异系数范围为0.46%至2.24%。该方法已被采用为第一法正式方法。
