Naviasky H
J Assoc Off Anal Chem. 1985 Sep-Oct;68(5):1055-7.
An ion-pair column chromatographic method was developed for the determination of trimethobenzamide hydrochloride in capsules and injection dosage forms. Detection is by UV spectrophotometry at 261 nm. Recoveries by the Associate Referee ranged from 98.3 to 101.0% for the drug substance. Results by 5 collaborators for capsules averaged 99.1% of labeled or theoretical with coefficients of variation (CVs) of 1.81% (reproducibility) and 1.17% (repeatability); results for injections averaged 100.4% of labeled or theoretical with CVs of 1.91% (reproducibility) and 0.69% (repeatability). The method has been adopted official first action.
已开发出一种离子对柱色谱法,用于测定胶囊剂和注射剂剂型中的盐酸曲美苄胺。采用紫外分光光度法在261nm波长处进行检测。副裁判测定的原料药回收率为98.3%至101.0%。5位协作人员测定胶囊剂的结果平均为标示量或理论量的99.1%,变异系数(CV)分别为1.81%(重现性)和1.17%(重复性);注射剂的结果平均为标示量或理论量的100.4%,CV分别为1.91%(重现性)和0.69%(重复性)。该方法已被官方首次采用。