title: Development and Validation of a Rapid RP-HPLC-DAD Analysis Method for the Simultaneous Quantitation of Paclitaxel and Lapatinib in a Polymeric Micelle Formulation.
abstract: A robust and rapid analysis method was developed and validated for the simultaneous assay of paclitaxel (PTX) and lapatinib (LPT) in a polymeric micelle formulation as a novel drug delivery system using high-performance liquid chromatography (HPLC). The assay was performed using the C18 MZ-Analytical Column (5 μm, 150 × 4.6 mm, OSD-3) which was protected with the C18 pre-column (5 μm, 4.0 × 4.6 mm, OSD-3). The mobile phase was composed of acetonitrile and water (70/30; V/V) with a flow rate of 0.5 mL/min and detection wavelength of 227 nm. Accuracy was reported as the relative error and was found to be less than 6.8%. The interday assay was evaluated to be 3.22% and 5.76% RSD for PTX and LPT, respectively. The intraday precision was found to be at its maximum value of 5.83% RSD. The limit of detection for both PTX and LPT was found to be 1 µg/mL by means of the newly developed method. The limit of quantitation for PTX and LPT was found to be 5 µg/mL. The calibration curves for both drugs were linear in the concentration range of 5 to 80 μg/mL. In vitro release for both drugs from the polymeric micelle was evaluated using the newly developed analysis method.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-645, Iran.
authors.forename: Ebrahim
authors.initials: E
authors.lastname: Saadat
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-645, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Ravar
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-645, Iran; Medical Biomaterials Research Center, Tehran University of Medical Sciences, Tehran 14399-56131, Iran.
authors.forename: Pouya
authors.initials: P
authors.lastname: Dehghankelishadi
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-645, Iran; Medical Biomaterials Research Center, Tehran University of Medical Sciences, Tehran 14399-56131, Iran.
authors.forename: Farid A
authors.initials: FA
authors.lastname: Dorkoosh
keywords: HPLC; Lapatinib; Paclitaxel; Pharmaceutics; Validation