Takahashi D M
J Pharm Sci. 1980 Feb;69(2):184-7. doi: 10.1002/jps.2600690217.
A rapid, simple, and accurate high-performance liquid chromatographic procedure using an amino-bonded microparticulate column is reported for the determination of chlorpromazine hydrochloride (I) and its two oxidation products, the sulfoxide (II) and the sulfone (III), in commercially available pharmaceutical dosage preparations. Simultaneous identification and quantitation of II and III in the presence of at least 100 times the amount of parent compound were achieved with selective fluorometric detection. Identification and quantitation of I were achieved by changing the fluorescence detection mode. A typical chromatographic run was completed within 15 min. The described procedure is simpler, more sensitive, and more accurate than the USP XIX methods, particularly for the analysis of II in injectables. Quantitation of II and III at levels as low as 0.1 microgram, representing 0.1% contamination, was demonstrated.
报道了一种使用氨基键合微粒柱的快速、简单且准确的高效液相色谱法,用于测定市售药物制剂中的盐酸氯丙嗪(I)及其两种氧化产物,即亚砜(II)和砜(III)。通过选择性荧光检测,在至少100倍母体化合物存在的情况下,实现了II和III的同时鉴定和定量。通过改变荧光检测模式实现了I的鉴定和定量。一次典型的色谱运行在15分钟内完成。所述方法比美国药典第十九版方法更简单、更灵敏、更准确,尤其适用于注射剂中II的分析。已证明能定量低至0.1微克的II和III,这相当于0.1%的污染水平。