Smith D J
J Chromatogr Sci. 1981 Feb;19(2):65-71. doi: 10.1093/chromsci/19.2.65.
A high performance liquid chromatographic analysis is described for chlorpromazine and some of its related compounds in tablet dosage forms and biological matrices using a dimethylsilane (RP-2) reversed-phase column packing and a mobile phase consisting of ammonium carbonate, acetonitrile, and water. The method will separate and quantitate mixtures of chlorpromazine sulfone, chlorpromazine sulfoxide, desmonomethylchlorpromazine sulfoxide, chlorpromazine, and desmonomethylchlorpromazine. After incorporation of the tablet dosage form or biological matrix in a solvent mixture consisting of dilute hydrochloric acid or ammonium carbonate, acetonitrile, and water, an aliquot is chromatographed and the components are detected and quantitated by their UV spectrophotometric absorption at 254 nm. For chlorpromazine and chlorpromazine sulfoxide hydrochlorides, the data show that temperatures ranging from 30 degrees-80 degrees C may be selected without affecting this analysis except to alter elution time, but the selected temperature must be controlled to +/- 1 degree C in order to achieve precise analytical results. The response of the chromatographic system in aqueous solution is linear over a concentration range of 19.4 ng-56 microgram/ml chlorpromazine. Adequate sensitivity, good selectivity, and reproducibility are shown for the analysis of chlorpromazine in single tablets.
本文描述了一种高效液相色谱分析法,用于分析片剂剂型和生物基质中的氯丙嗪及其一些相关化合物。该方法使用二甲基硅烷(RP - 2)反相柱填料和由碳酸铵、乙腈和水组成的流动相。该方法可分离并定量氯丙嗪砜、氯丙嗪亚砜、去甲氯丙嗪亚砜、氯丙嗪和去甲氯丙嗪的混合物。将片剂剂型或生物基质加入由稀盐酸或碳酸铵、乙腈和水组成的溶剂混合物中后,取一份等分试样进行色谱分析,并通过其在254 nm处的紫外分光光度吸收检测和定量各组分。对于盐酸氯丙嗪和盐酸氯丙嗪亚砜,数据表明可以选择30℃至80℃的温度范围,除了改变洗脱时间外不会影响该分析,但所选温度必须控制在±1℃以内,以获得精确的分析结果。色谱系统在水溶液中的响应在氯丙嗪浓度范围为19.4 ng至56μg/ml时呈线性。该方法对单片中氯丙嗪的分析显示出足够的灵敏度、良好的选择性和重现性。