1. Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation
- Author
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Ebrahim Saadat, Farid Abedin Dorkoosh, Fatemeh Ravar, Pouya Dehghankelishadi, Saadat, Ebrahim, Ravar, Fatemeh, Dehghankelishadi, Pouya, and Dorkoosh, Farid A
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Paclitaxel ,Calibration curve ,Pharmaceutical Science ,Lapatinib ,030226 pharmacology & pharmacy ,01 natural sciences ,High-performance liquid chromatography ,03 medical and health sciences ,chemistry.chemical_compound ,paclitaxel ,0302 clinical medicine ,Validation ,medicine ,lapatinib ,Acetonitrile ,Detection limit ,validation ,Chromatography ,Chemistry ,Pharmaceutics ,pharmaceutics ,010401 analytical chemistry ,0104 chemical sciences ,Drug delivery ,HPLC ,medicine.drug ,Research Article - 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.
- Published
- 2015
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