Abstract
Purpose: To develop a simple, novel, sensitive and rapid reverse phase high performance liquid chromatographic method for simultaneous determination of paclitaxel, sorafenib and omeprazole in standard solutions and spiked human plasma and its application to the in-vitro and in-vivo evaluation of paclitaxel polymeric nanoparticle formulations.Methods: The method was tested for the assessment of paclitaxel, omeprazole and sorafenib using tamoxifen citrate as internal standard. The analysis was performed at a wavelength of 235 nm using Thermo HS C18 column, 40 °C column oven temperature, acetonitrile and water (70:30 v/v, pH 3.37 adjusted with phosphoric acid) as a mobile phase and at a flow rate of 0.8 ml/min. All analytes were extracted by simple protein precipitation method using acetonitrile. The linearity was assessed in the concentration range of 1 - 2000 ng/mL for paclitaxel, omeprazole and sorafenib.Results: The developed chromatographic method effectively separated omeprazole, paclitaxel, sorafenib and IS with retention time of 3.93, 5.18, 6.43 and 9.93 min, respectively. The chromatograms of the three target compounds and IS showed good resolution and peak separation. The LOD of the method was 1, 5 and. 5 ng/mL while the LOQ was 2, 7.5 and 10 ng/mL, for paclitaxel, sorafenib and omeprazole, respectively.Conclusion: The proposed RP-HPLC–UV method for the assessment of paclitaxel, sorafenib and omeprazole in standard solutions and spiked plasma is simple, economical, sensitive and robust. The method is also suitable for the analysis of paclitaxel in nanoformulations and for its pharmacokinetic studies in an animal model.
Highlights
Paclitaxel, a di-terpenoid pseudoalkaloid, discovered in 1962 and isolated from pacific yew tree bark, Taxus Brevifolia [1] is a mitotic inhibitor used in cancer chemotherapy [2]
Linearity was measured using a least squares regression equation. Both LLOD and LLOQ were determined by using HPLC software (S/N ratio) in order to find out sensitivity of the method
Various solvents were tested as mobile phase for the analytical study of target compounds
Summary
Paclitaxel, a di-terpenoid pseudoalkaloid, discovered in 1962 and isolated from pacific yew tree bark, Taxus Brevifolia [1] is a mitotic inhibitor used in cancer chemotherapy [2]. It represents the first generation of the taxanes family of drugs [3]. A paclitaxel-tubulin complex is formed by its binding to the β-subunit of tubulin (building block of microtubules) and arresting the ability of tubulin to disassemble, which adversely affects cell function [6]. Paclitaxel inhibits metaphase anaphase transition, and binds to B-cell. Paclitaxel inhibits metaphase anaphase transition, and binds to B-cell. leukemia 2 (an apoptosis stopping protein), arresting its function by inducing apoptosis [7]
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