title: Validated HPLC Method for the Determination of Paclitaxel-related Substances in an Intravenous Emulsion Loaded with a Paclitaxel-Cholesterol Complex.
abstract: A high-performance liquid chromatography method was developed for the determination of related substances in an intravenous emulsion loaded with a paclitaxel-cholesterol complex. The separation was achieved using Agilent Eclipse XDB-C18 column (150×4.6 mm, 3.5 μm), which was kept at 40°. The gradient mobile phase consisted of acetonitrile and water with a flow rate of 1.2 ml/min. The ultraviolet detection wavelength was set at 227 nm. The preparation of the sample solution began with the addition of anhydrous sodium sulphate to break the emulsion. Then, methanol and ethyl ether were added to pick up the drug and remove the accessories of the emulsion by extraction and centrifugation. Finally, paclitaxel was enriched by a nitrogen blow method and resolved with a mixture of methanol:glacial acetic acid (200:1). The method was proven to be selective, sensitive, robust, linear, repeatable, accurate and suitable for the determination of paclitaxel-related substances in the emulsion formulations, and the major degradation products in the potential pharmaceutical product were 7-epipaclitaxel and 10-deacetylpaclitaxel.
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing City Key Laboratory of Drug Delivery Technology and Novel Formulations, 1 Xiannongtan Street, Beijing-100050, China.
authors.forename: X J
authors.initials: XJ
authors.lastname: Xia
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing City Key Laboratory of Drug Delivery Technology and Novel Formulations, 1 Xiannongtan Street, Beijing-100050, China.
authors.forename: J
authors.initials: J
authors.lastname: Peng
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing City Key Laboratory of Drug Delivery Technology and Novel Formulations, 1 Xiannongtan Street, Beijing-100050, China.
authors.forename: P X
authors.initials: PX
authors.lastname: Zhang
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing City Key Laboratory of Drug Delivery Technology and Novel Formulations, 1 Xiannongtan Street, Beijing-100050, China.
authors.forename: D J
authors.initials: DJ
authors.lastname: Jin
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing City Key Laboratory of Drug Delivery Technology and Novel Formulations, 1 Xiannongtan Street, Beijing-100050, China.
authors.forename: Y L
authors.initials: YL
authors.lastname: Liu
keywords: Paclitaxel; determination; emulsion; highperformance liquid chromatography; related substances