Barth H G, Conner A Z
J Chromatogr. 1977 Jan 21;131:375-81. doi: 10.1016/s0021-9673(00)80954-1.
An improved high-pressure liquid chromatographic method for the determination of doxorubicin hydrochloride (Adriamycin TM) in pharmaceutical preparations has been developed. A liquid-solid system using microporous silica (Zorbax) as the stationary phase and 3.8% 0.5 M sodium acetate buffer (pH 4.5) in isopropanol as the mobile phase gave optimum separation of doxorubicin hydrochloride from the excipient (lactose) and minor impurities. The doxorubicin hydrochloride content of a 10-mg vial can be determined in 25-30 min with a relative standard deviation of 3.2%. Results compare favorably with those obtained by established thin-layer chromatography and spectrophotometric procedures. The sensitivity of the method is sufficiently high (nanogram range) for possible use in metabolic or pharmacological studies.
已开发出一种改进的高压液相色谱法，用于测定药物制剂中的盐酸多柔比星（阿霉素TM）。采用微孔硅胶（Zorbax）作为固定相，以3.8%的0.5M醋酸钠缓冲液（pH 4.5）的异丙醇溶液作为流动相的液固系统，能使盐酸多柔比星与辅料（乳糖）及微量杂质实现最佳分离。10毫克小瓶中的盐酸多柔比星含量可在25 - 30分钟内测定，相对标准偏差为3.2%。结果与既定的薄层色谱法和分光光度法相比具有优势。该方法的灵敏度足够高（纳克范围），可用于代谢或药理学研究。
