Abstract
Purpose: To quantify the multi-targeted tyrosine kinase inhibitor, crizotinib, in human plasma and bulk powder by highly sensitive micellar enhanced spectrofluorimetric procedure. Method: The developed procedure was based on measuring the fluorescence intensity of crizotinib (CRZ) in sodium dodecyl sulphate (SDS) micellar system at 404 nm after excitation at 271 nm. Validation of the developed procedure was carried out following ICH (International Council for Harmonization) guidelines. Results: Maximum fluorescence intensity (FI) was attained by addition of 0.2 mL SDS and 0.2 mL HCl (1N) to CRZ aliquots and then dilution with distilled water. There was a linear relationship between the FI of CRZ and its concentration over the range, 5 – 400 ng/mL, with limit of detection and of quantification of 1.857 and 5.628 ng/mL respectively. The developed procedure was successfully applied to assay CRZ in pure powder form and spiked human plasma with mean recovery of 100.68 ± 0.37 and 99.98 ± 0.20 %, respectively. Conclusion: The developed procedure is simple and sensitive, and can be applied to routine analysis of CRZ in pure powder form as well as in clinical laboratories for the determination of CRZ in plasma. Keywords: Crizotinib, Spectrofluorimetry, Micelle, Human plasma, Sodium dodecyl sulphate
Highlights
Crizotinib (CRZ, Figure 1) is one of the new tyrosine kinase inhibitors (TKIs) which is chemically known as 3-[(1R)-1-(2, 6-dichloro-3fluorophenyl) ethoxy]-5-(1-piperidin-4-ylpyrazol4-yl) pyridine-2-amine
Literature review revealed that CRZ was assayed in plasma by liquid chromatography coupled with either tandem mass spectrometry [6,7,8,9] or fluorescence detection [10]
Micellar enhanced spectrofluorimetric method was developed for assaying CRZ (Figure 1) in plasma
Summary
Crizotinib (CRZ, Figure 1) is one of the new tyrosine kinase inhibitors (TKIs) which is chemically known as 3-[(1R)-1-(2, 6-dichloro-3fluorophenyl) ethoxy]-5-(1-piperidin-4-ylpyrazol4-yl) pyridine-2-amine. Literature review revealed that CRZ was assayed in plasma by liquid chromatography coupled with either tandem mass spectrometry [6,7,8,9] or fluorescence detection [10] These chromatographic methods suffered from complexity and being expensive. Application of micellar enhancement approach in spectrofluorimetry was applied to assay small molecules by virtue of its high sensitivity [14,15,16] due to the ability of the formed micelle to decrease the free rotational motions and protect the analyte molecules from the radiationless deactivation process [16] This approach represents effective and echo-friendly methodology because there is no application of organic solvents throughout the whole study
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