Determination of doxorubicin hydrochloride in pharmaceutical preparations using high-pressure liquid chromatography.

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.