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

Development and Validation of Novel Rp-HPLC-Dad Method for Quantification of Lapatinib Ditosylate in Newer Nano-Liposome Formulation: A Quality by Design (Qbd) Approach

“…The accuracy of the previous HPLC method for estimation of Lapatinib was reported between 99.85-100.8%, however, the present method was found in the range of 99.51% to 102.16% recovery and 0.39 to 0.26 % RSD, respectively [41]. The precision of the method was found satisfactory as compared to previously reported methods reported for the estimation of Lapatinib and degraded products using HPLC-MS [42]. In the earlier studies, performed by LC-MS/MS and UPLC-MS-MS, the RSD percentages varied from 3.9 to 8.1%, and 2.84% while in the present method the maximum RSD was calculated to be 1.63% intra-day and 1.92% inter-day precision respectively [43].…”

Gold-Based Nanoplataform for the Treatment of Anaplastic Thyroid Carcinoma: A Step Forward

“…To determine the conjugation efficiency of lapatinib, the concentration of this ligand present in the supernatant was determined by HPLC (Hitachi System LaCrom Elite, Column oven, Diode Array Detector UV-vis and Pump, Tokyo, Japan), following a protocol described elsewhere [ 30 ]. The supernatants were analysed using a Column Water Symmetry C18 (5 µm, 4.6 × 150 mm) with isocratic flow of 0.5 mL/min, and a mobile phase composed of acetonitrile/water (70:30; v / v ).…”

Modern Instrumental Methods for Qualitative and Quantitative Analysis of Lapatinib in Biological Fluids and Dosage Forms (Review)

“…Some researchers point to the efficacy of the combined use of lapatinib and paclitaxel in patients with squamous cell carcinoma of the esophagus and HER2-positive breast cancer [31,32]. Therefore, a reliable and fast RP-HPLC-DAD method was developed to determine these two drugs simultaneously [33]. This method was also used to assess the release profile of paclitaxel and lapatinib from polymeric micelle formulation.…”