Yuen S M, Lehr G
Food and Drug Administration, New York Regional Laboratory, Brooklyn 11232.
J Assoc Off Anal Chem. 1991 May-Jun;74(3):461-4.
A specific liquid chromatographic method was developed for determination of clidinium bromide and clidinium bromide-chlordiazepoxide hydrochloride combinations in capsules. The procedure uses a Partisil 10 ODS-3 column and a mobile phase consisting of acetonitrile-0.3M ammonium phosphate (32 + 68) (pH = 4.3). The detection wavelength is 235 nm. Accuracy, reproducibility, and linearity were within accepted criteria. Four commercial samples of the single ingredient were tested; results compared favorably with the compendial method. Two commercial samples of the combination product were tested by the proposed method and results reported. The system was found to be free from any interferences from the 4 known related compounds of the 2 major components and is useful as a screening procedure for 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one-4-oxide, the principal degradation product of chlordiazepoxide hydrochloride.
建立了一种特定的液相色谱法，用于测定胶囊中溴化氯氮䓬以及溴化氯氮䓬 - 盐酸氯氮䓬复方制剂的含量。该方法采用Partisil 10 ODS - 3色谱柱，流动相为乙腈 - 0.3M磷酸铵（32 + 68）（pH = 4.3）。检测波长为235 nm。准确度、重现性和线性均在可接受标准范围内。对4个单成分的商业样品进行了测试，结果与药典方法相比良好。用所提出的方法对2个复方产品的商业样品进行了测试并报告了结果。该系统未发现受到2种主要成分的4种已知相关化合物的任何干扰，并且可用作盐酸氯氮䓬主要降解产物7 - 氯 - 1,3 - 二氢 - 5 - 苯基 - 2H - 1,4 - 苯并二氮杂䓬 - 2 - 酮 - 4 - 氧化物的筛选程序。
