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Sci. Pharm. 2016, 84(2), 333-345; doi:10.3797/scipharm.1507-03

Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation

1
Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran P.O. Box 14155-645, Iran
2
Medical Biomaterials Research Center, Tehran University of Medical Sciences, Tehran 14399-56131, Iran
*
Author to whom correspondence should be addressed.
Received: 4 July 2015 / Accepted: 29 September 2015 / Published: 29 September 2015
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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.
Keywords: Paclitaxel; Lapatinib; Validation; Pharmaceutics; HPLC Paclitaxel; Lapatinib; Validation; Pharmaceutics; HPLC
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

SAADAT, E.; RAVAR, F.; DEHGHANKELISHADI, P.; DORKOOSH, F.A. Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation. Sci. Pharm. 2016, 84, 333-345.

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