Burce G L, Boehlert J P
J Pharm Sci. 1978 Mar;67(3):424-6. doi: 10.1002/jps.2600670345.
A stability-indicating assay for the degradation products of procarbazine hydrochloride was developed using high-pressure liquid chromatography. The method uses a buffered methanol-water mobile phase on a reversed-phase column. Concentrations of degradation products as low as 0.04 mg/ml, 0.02% degradation, can be quantitated using an internal standard of cinnamyl alcohol. The typical range for degradation products in procarbazine capsules is 0.1-0.5% after as long as 4.5 years.
采用高压液相色谱法开发了一种测定盐酸丙卡巴肼降解产物的稳定性指示分析方法。该方法在反相柱上使用缓冲甲醇 - 水流动相。使用肉桂醇作为内标物，可对低至0.04 mg/ml（降解0.02%）的降解产物浓度进行定量。在长达4.5年的时间里，丙卡巴肼胶囊中降解产物的典型范围为0.1 - 0.5%。
