Spectrophotometric Methods for Determination of Sunitinib in Pharmaceutical Dosage Forms Based on Ion-pair Complex Formation

Document Type : Research article

Authors

1 Department of Medicinal Chemistry, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

2 Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Abstract

Three rapid spectrophotometric methods were developed for the determination of sunitinib based on the formation of ion-pair complex in acidic medium with bromocresol purple, bromothymol blue, and bromophenol blue. The formed ion-pair complexes, extractable with chloroform, were measured at 422 nm for bromocresol purple, 425 nm for bromothymol blue and 427 nm for bromophenol blue. All these methods were optimized for the pH of buffer and the volume of the reagent. The methods were linear over the range of 1-200 µg/mL for bromocresol purple, 1-150 µg/mL for bromothymol blue, and 2-200 µg/mL for bromophenol blue with a very low limit of quantification and acceptable accuracy and precision. Using the proposed methods for determination of sunitinib in pharmaceutical dosage forms showed reliable results comparable to previously published method.

Graphical Abstract

Spectrophotometric Methods for Determination of Sunitinib in Pharmaceutical Dosage Forms Based on Ion-pair Complex Formation

Keywords


1-         Rini BI. Vascular endothelial growth factor-targeted therapy in renal cell carcinoma: current status and future directions. Clin. Cancer Res. (2007) 13: 1098-106.
2-         Fabian MA, Biggs WH 3rd, Treiber DK, Atteridge CE, Azimioara MD, Benedetti MG, Carter TA, Ciceri P, Edeen PT, Floyd M, Ford JM, Galvin M, Gerlach JL, Grotzfeld RM, Herrgard S, Insko DE, Insko MA, Lai AG, Lélias JM, Mehta SA, Milanov ZV, Velasco AM, Wodicka LM, Patel HK, Zarrinkar PP, Lockhart DJ.  A small molecule-kinase interaction map for clinical kinase inhibitors. Nat. Biotechnol. (2005) 23: 329-36.
3-         Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM. SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol. Cancer Ther. (2003) 2: 471-8.
4-         Chow LQM, Eckhardt SG. Sunitinib: From Rational Design to Clinical Efficacy. J.  Clin. Oncol. (2007) 25: 884-96.
5-         Faivre S, Demetri G, Sargent W, Raymond E. Molecular basis for sunitinib efficacy and future clinical development. Nat. Rev. Drug Discov. (2007) 6: 734-45.
6-         Adams VR, Leggas M. Sunitinib malate for the treatment of metastatic renal cell carcinoma and gastrointestinal stromal tumors. Clin. Ther. (2007) 29: 1338-53.
7-         Atkins M, Jones CA, Kirkpatrick P. Sunitinib maleate. Nat.  Rev. Drug Discov. (2006) 5: 279-280.
8-         Fiedler W, Serve H, Döhner H, Schwittay M, Ottmann OG, O'Farrell AM, Bello CL, Allred R, Manning WC, Cherrington JM, Louie SG, Hong W, Brega NM, Massimini G, Scigalla P, Berdel WE, Hossfeld DK. A phase 1 study of SU11248 in the treatment of patients with refractory or resistant acute myeloid leukemia (AML) or not amenable to conventional therapy for the disease. Blood (2005) 105: 986-93.
9-         Bello CL, Sherman L, Zhou J, Verkh L, Smeraglia J, Mount J, Klamerus KJ. Effect of food on the pharmacokinetics of sunitinib malate (SU11248), a multi-targeted receptor tyrosine kinase inhibitor: results from a phase I study in healthy subjects. Anticancer Drugs (2006) 17: 353-8
10-       Britten CD, Kabbinavar F, Hecht JR, Bello CL, Li J, Baum C, Slamon D. A phase I and pharmacokinetic study of sunitinib administered daily for 2 weeks, followed by a 1-week off period. Cancer Chemother. Pharmacol. (2008) 61: 515-24.
11-       Minkin P, Zhao M, Chen Z, Ouwerkerk J, Gelderblom H, Baker DS. Quantification of sunitinib in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J. Chromatogr. B (2008) 874: 84-8.
12-       Lankheet NAG, Hillebrand MJX, Rosing H, Schellens JHM, Beijnen JH and Huitema ADR. Method development and validation for the quantification of dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, sorafenib and sunitinib in human plasma by liquid chromatography coupled with tandem mass spectrometry. Biomed. Chromatogr. (2013) 27: 466-76.
13-       Qiu F, Bian W, Li J and Ge Z. Simultaneous determination of sunitinib and its two metabolites in plasma of Chinese patients with metastatic renal cell carcinoma by liquid chromatography–tandem mass spectrometry. Biomed. Chromatogr. (2013) 27: 615-21.
14-       de Bruijn P, Sleijfer S, Lam MH, Mathijssen RHJ, Wiemer EAC, Loos WJ. Bioanalytical method for the quantification of sunitinib and its n-desethyl metabolite SU12662 in human plasma by ultra performance liquid chromatography/tandem triple-quadrupole mass spectrometry. J. Pharm. Biomed. Anal. (2010) 51: 934-41.
15-       Honeywell R, Yarzadah K, Giovannetti E, Losekoot N, Smit EF, Walraven M, Lind JSW, Tibaldi C, Verheul HM, Peters GJ. Simple and selective method for the determination of various tyrosine kinase inhibitors used in the clinical setting by liquid chromatography tandem mass spectrometry. J. Chromatogr. B (2012) 878:1059-68.
16-       Blanchet B, Saboureau C, Benichou AS, Billemont B, Taieb F, Ropert S, Dauphin A, Goldwasser F, Tod M. Development and validation of an HPLC-UV-visible method for sunitinib quantification in human plasma. Clin. Chim. Acta (2009) 404: 134-9.
17-       Etienne-Grimaldi MC, Renée N, Izzedine H, Milano G. A routine feasible HPLC analysis for the anti-angiogenic tyrosine kinase inhibitor, sunitinib, and its main metabolite, SU12662, in plasma. J. Chromatogr. B  (2009) 877: 3757-61.