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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Articles in this Issue were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence. Articles are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
Open AccessArticle

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.
Sci. Pharm. 2016, 84(2), 333-345; https://doi.org/10.3797/scipharm.1507-03
Received: 4 July 2015 / Accepted: 29 September 2015 / Published: 29 September 2015
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
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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