Haneke A C, Crawford J, Aszalos A
J Pharm Sci. 1981 Oct;70(10):1112-5. doi: 10.1002/jps.2600701006.
A fast and sensitive high-pressure liquid chromatographic method was developed for the quantitation of doxorubicin, daunorubicin, and their aglycones in pharmaceutical preparations. Because its higher pH extends column life while permitting determination of impurities, this system represents an improvement over previously published methods. It utilizes a C18 bonded silica gel column and a solvent system consisting of methanol-0.01 M monobasic ammonium phosphate aqueous solution (65:35) at pH 4.0 and 1600 psi of pressure. The accuracy of the doxorubicin and daunorubicin determinations, expressed as the coefficient of variation, is 1.65 and 1.27% respectively. The aglycones can be determined with a precision of less than 1.3%.
开发了一种快速灵敏的高压液相色谱法，用于定量测定药物制剂中的阿霉素、柔红霉素及其糖苷配基。由于该系统具有较高的pH值，可延长色谱柱寿命，同时允许测定杂质，因此是对先前发表方法的改进。它使用C18键合硅胶柱和由甲醇-0.01M磷酸二氢铵水溶液（65:35）组成的溶剂系统，pH值为4.0，压力为1600psi。阿霉素和柔红霉素测定的准确度以变异系数表示，分别为1.65%和1.27%。糖苷配基的测定精密度小于1.3%。
