Kensler T T, Behme R J, Brooke D
J Pharm Sci. 1979 Feb;68(2):172-4. doi: 10.1002/jps.2600680213.
A reversed-phase high-performance liquid chromatographic technique is described for the analysis of cyclophosphamide in the presence of its hydrolysis products. The drug was quantified using a UV detector at a low wavelength. A single band was observed for the intact drug, which was well separated from tis hydrolysis product(s). Quantificaiton was obtained with adequate precision by the use of an injector loop or a suitable internal standard (hydrocortisone). The technique requires no extraction of the drug from aqueous solution or derivatization for analysis. The method was applied to partially hydrolyzed and to known solutions of cyclophosphamide. With suitable modification, the method may be useful for analysis of dosage forms but probably lacks the sensitivity necessary for analysis of the drug in biological samples.
描述了一种反相高效液相色谱技术,用于分析存在水解产物情况下的环磷酰胺。使用低波长紫外检测器对该药物进行定量。完整药物呈现单一谱带,与水解产物分离良好。通过使用进样环或合适的内标(氢化可的松)可获得足够精确的定量结果。该技术无需从水溶液中提取药物或进行衍生化分析。该方法应用于部分水解的环磷酰胺和已知的环磷酰胺溶液。经过适当修改,该方法可能对剂型分析有用,但可能缺乏分析生物样品中药物所需的灵敏度。