Development of a Rapid and Precise Reversed-phase High-performance Liquid Chromatography Method for Analysis of Docetaxel in Rat Plasma: Application in Single-dose Pharmacokinetic Studies of Folate-targeted Micelles Containing Docetaxel

Document Type : Original Article

Authors

1 Department of Pharmaceutics, School of Pharmacy and Novel Drug Delivery Systems Research Centre, Isfahan University of Medical Sciences, Isfahan, Iran

2 Physiology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

3 Department of Medicinal Chemistry, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran

Abstract

Background: A simple and sensitive reversed-phase high-performance liquid chromatography (HPLC) method based on liquid-liquid extraction was established and validated for determination of docetaxel (DTX) in plasma of rat. Materials and Methods: Samples were spiked with paclitaxel as the internal standard and the chromatographic separation was carried out using C18 HPLC column. The mobile phase consisted of a mixture of acetonitrile/water with the ratio of 60/40 v/v. The ultraviolet detector was operated at 230 nm, and the flow rate of mobile phase was 1 ml/min. The method was validated for linearity, precision, accuracy, recovery, and limit of quantification (LOQ). Then the method was applied to quantify DTX in the rat plasma after intravenous (IV) administration of the self-assembled micelles of folate-targeted Synpronic F127/cholesterol (FA-PF127-Chol) loaded with DTX and Taxotere® as the reference marketed solution of DTX. The blood samples were taken from the ophthalmic vein at predetermined time intervals after treatment. Results: Calibration curve was linear between the concentration ranges of 0.1–7.5 μg/ml with the relative standard deviation % and evaluating error % ranged from 2.263 to 15.53 and −12.75 to 12.7 for intra- and inter-day validity, respectively. The mean recovery of the drug after plasma extraction was 95.67 ± 0.99% for the concentration of 1 μg/ml. The LOQ and the limit of detection for DTX in serum were 100 ng/ml and 30 ng/ml, respectively. Conclusions: The results indicated that the developed method could be adopted for pharmacokinetic studies of DTX-loaded FA-PF127-Chol micelles and Taxotere® in rat.

Keywords

1.
Liu Z, Liu D, Wang L, Zhang J, Zhang N. Docetaxel-loaded pluronic p123 polymeric micelles: In vitro and in vivo evaluation. Int J Mol Sci 2011;12:1684-96.  Back to cited text no. 1
[PUBMED]    
2.
Wang X, Wang Y, Chen X, Wang J, Zhang X, Zhang Q. NGR-modified micelles enhance their interaction with CD13-overexpressing tumor and endothelial cells. J Control Release 2009;139:56-62.  Back to cited text no. 2
[PUBMED]    
3.
Hu K, Cao S, Hu F, Feng J. Enhanced oral bioavailability of docetaxel by lecithin nanoparticles: Preparation, in vitro, and in vivo evaluation. Int J Nanomedicine 2012;7:3537-45.  Back to cited text no. 3
[PUBMED]    
4.
Jhaveri AM, Torchilin VP. Multifunctional polymeric micelles for delivery of drugs and siRNA. Front Pharmacol 2014;5:77.  Back to cited text no. 4
[PUBMED]    
5.
Wang C, Mallela J, Mohapatra S. Pharmacokinetics of polymeric micelles for cancer treatment. Curr Drug Metab 2013;14:900-9.  Back to cited text no. 5
[PUBMED]    
6.
Kedar U, Phutane P, Shidhaye S, Kadam V. Advances in polymeric micelles for drug delivery and tumor targeting. Nanomedicine 2010;6:714-29.  Back to cited text no. 6
[PUBMED]    
7.
Varshosaz J, Taymouri S, Hassanzadeh F, Javanmard SH, Rostami M. Folated synperonic-cholesteryl hemisuccinate polymeric micelles for the targeted delivery of docetaxel in melanoma. Biomed Res Int 2015;2015:746093.  Back to cited text no. 7
[PUBMED]    
8.
Cho HJ, Park JW, Yoon IS, Kim DD. Surface-modified solid lipid nanoparticles for oral delivery of docetaxel: Enhanced intestinal absorption and lymphatic uptake. Int J Nanomedicine 2014;9:495-504.  Back to cited text no. 8
[PUBMED]    
9.
Lee SW, Yun MH, Jeong SW, In CH, Kim JY, Seo MH, et al. Development of docetaxel-loaded intravenous formulation, Nanoxel-PM™ using polymer-based delivery system. J Control Release 2011;155:262-71.  Back to cited text no. 9
[PUBMED]    
10.
Hou W, Watters JW, McLeod HL. Simple and rapid docetaxel assay in plasma by protein precipitation and high-performance liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2004;804:263-7.  Back to cited text no. 10
[PUBMED]    
11.
Le Garrec D, Gori S, Luo L, Lessard D, Smith DC, Yessine MA, et al. Poly(N-vinylpyrrolidone)-block-poly(D, L-lactide) as a new polymeric solubilizer for hydrophobic anticancer drugs: In vitro and in vivo evaluation. J Control Release 2004;99:83-101.  Back to cited text no. 11
[PUBMED]    
12.
Rosing H, Lustig V, Koopman FP, ten Bokkel Huinink WW, Beijnen JH. Bio-analysis of docetaxel and hydroxylated metabolites in human plasma by high-performance liquid chromatography and automated solid-phase extraction. J Chromatogr B Biomed Sci Appl 1997;696:89-98.  Back to cited text no. 12
[PUBMED]    
13.
Garg MB, Ackland SP. Simple and sensitive high-performance liquid chromatography method for the determination of docetaxel in human plasma or urine. J Chromatogr B Biomed Sci Appl 2000;748:383-8.  Back to cited text no. 13
[PUBMED]    
14.
Ciccolini J, Catalin J, Blachon MF, Durand A. Rapid high-performance liquid chromatographic determination of docetaxel (Taxotere) in plasma using liquid-liquid extraction. J Chromatogr B Biomed Sci Appl 2001;759:299-306.  Back to cited text no. 14
[PUBMED]    
15.
Loos WJ, Verweij J, Nooter K, Stoter G, Sparreboom A. Sensitive determination of docetaxel in human plasma by liquid-liquid extraction and reversed-phase high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1997;693:437-41.  Back to cited text no. 15
[PUBMED]    
16.
Zufía López L, Aldaz Pastor A, Aramendia Beitia JM, Arrobas Velilla J, Giraldez Deiró J. Determination of docetaxel and Paclitaxel in human plasma by high-performance liquid chromatography: Validation and application to clinical pharmacokinetic studies. Ther Drug Monit 2006;28:199-205.  Back to cited text no. 16
    
17.
Emami J, Fallah R, Ajami A. A rapid and sensitive HPLC method for the analysis of celecoxib in human plasma: Application to pharmacokinetic studies. DARU 2008;16:211-7.  Back to cited text no. 17
    
18.
Talari R, Varshosaz J, Mostafavi A, Nokhodchi A. Development and validation of anovel RP-HPLC method for pharmacokinetic studies of gliclazide in rat. Farmacia 2011;59:388-95.  Back to cited text no. 18
    
19.
Kim SY, Lee YM, Shin HJ, Kang JS. Indomethacin-loaded methoxy poly (ethylene glycol)/poly(epsilon-caprolactone) diblock copolymeric nanosphere: Pharmacokinetic characteristics of indomethacin in the normal Sprague-Dawley rats. Biomaterials 2001;22:2049-56.  Back to cited text no. 19
[PUBMED]    
20.
Zhao M, Su M, Lin X, Luo Y, He H, Cai C, et al. Evaluation of docetaxel-loaded intravenous lipid emulsion: Pharmacokinetics, tissue distribution, antitumor activity, safety and toxicity. Pharm Res 2010;27:1687-702.  Back to cited text no. 20
[PUBMED]