Imatinib quantification in rat plasma by high performance liquid chromatography with ultra violet detection - An application to preclinical pharmacokinetic study

R. Shetty, S. Kini, P. Musmade, A. Theerthahalli, C. Mohan, K.M. Bhat, J. Patel, V. Kumar

Research output: Contribution to journalArticle

Abstract

A simple and robust method for quantification of imatinib in rat plasma has been established using high performance liquid chromatography with UV detection. Mizolastine was used as an internal standard (IS). imatinib and internal standard in plasma sample were extracted using simple protein precipitation technique. The samples were injected into a C18 reverse-phase phenyl column and mobile phase used was acetonitrile - phosphate buffer (pH3.2; 25.0 mM) (24:76%, v/v) at a flow rate of 1.0 mL min-1 using ultraviolet detector. imatinib and internal standard were detected without any interference from rat plasma. Detection of imatinib in rat plasma by the high performance liquid chromatography method was accurate and precise with a quantitation limit of 20.0 ng mL-1. The proposed method was validated with linearity range of 20.0 - 10000.0 ng mL-1. Reproducibility, recovery and stability of the method were evaluated. This method has been successfully applied to pharmacokinetic evaluation of imatinib liposome formulation.
Original languageEnglish
Pages (from-to)752-760
Number of pages9
JournalPharmacologyonline
Volume3
Publication statusPublished - 2008

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Pharmacokinetics
High Pressure Liquid Chromatography
mizolastine
Liposomes
Buffers
Phosphates
Imatinib Mesylate
Proteins

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@article{f5159f42a1114c23b5d6694b72e0923a,
title = "Imatinib quantification in rat plasma by high performance liquid chromatography with ultra violet detection - An application to preclinical pharmacokinetic study",
abstract = "A simple and robust method for quantification of imatinib in rat plasma has been established using high performance liquid chromatography with UV detection. Mizolastine was used as an internal standard (IS). imatinib and internal standard in plasma sample were extracted using simple protein precipitation technique. The samples were injected into a C18 reverse-phase phenyl column and mobile phase used was acetonitrile - phosphate buffer (pH3.2; 25.0 mM) (24:76{\%}, v/v) at a flow rate of 1.0 mL min-1 using ultraviolet detector. imatinib and internal standard were detected without any interference from rat plasma. Detection of imatinib in rat plasma by the high performance liquid chromatography method was accurate and precise with a quantitation limit of 20.0 ng mL-1. The proposed method was validated with linearity range of 20.0 - 10000.0 ng mL-1. Reproducibility, recovery and stability of the method were evaluated. This method has been successfully applied to pharmacokinetic evaluation of imatinib liposome formulation.",
author = "R. Shetty and S. Kini and P. Musmade and A. Theerthahalli and C. Mohan and K.M. Bhat and J. Patel and V. Kumar",
note = "Export Date: 10 November 2017 Correspondence Address: Shetty, R.; Manipal College of pharmaceutical Sciences, Manipal 576 104 Udupi, Karnataka, India; email: shettyr78@gmail.com Chemicals/CAS: acetonitrile, 75-05-8; imatinib, 152459-95-5, 220127-57-1; mizolastine, 108612-45-9; phosphate, 14066-19-4, 14265-44-2 References: Druker, B.J., STI571 (Gleevec) as a paradigm for cancer therapy (2002) Trends Mol. Med, 8, pp. S14-S18; Atwell, S., Adams, J.M., Badger, J., A Novel Mode of Gleevec, Binding Is Revealed by the Structure of Spleen Tyrosine Kinase (2004) J. Biol. Chem, 279, pp. 55827-55832; Corless, C.L., Fletcher, J.A., Heinrich, M.C., Biology of Gastrointestinal Stromal Tumors (2004) J. Clin Oncol, 22, pp. 3813-3825; Leis, J.F., Primack, S.L., Schubach, S.E., Curtin, P.T., Druker, B.J., Maziarz, R.T., Management of life- threatening pulmonary leukostasis with single agent imatinib mesylate during CML myeloid blast crisis (2004) Haematologica, 89, pp. ECR30; Morishima, Y., Ogura, M., Nishimura, M., Efficacy and Safety of Imatinib Mesylate for Patients in the First Chronic Phase of Chronic Myeloid Leukemia: Results of a Japanese Phase II Clinical Study (2004) Int. J. Hematol, 80, pp. 261-266; Velpandian, T., Mathur, R., Agarwal, N.K., Arora, B., Kumar, L., Gupta, S.K., Development and validation of a simple liquid chromatographic method with ultraviolet detection for the determination of imatinib in biological samples (2004) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 804, pp. 431-434; Neville, K., Parise, R.A., Thompson, P., Plasma and cerebrospinal fluid pharmacokinetics of imatinib after administration to nonhuman primates (2004) Clin. Cancer Res, 10, pp. 2525-2529; Widmer, N., B{\'e}guin, A., Rochat, B., Determination of imatinib (Gleevec) in human plasma by solid-phase extraction-liquid chromatography-ultraviolet absorbance detection (2004) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 803, pp. 285-292; Le Coutre, P., Kreuzer, K.A., Pursche, S., (2004) Cancer Chemother. Pharmacol, 53, pp. 313-323; Oostendorp, R.L., Beijnen, J.H., Schellens, J.H., Tellingen, O., Determination of imatinib mesylate and its main metabolite (CGP74588) in human plasma and murine specimens, , by ion-pairing; reversed-phase high-performance liquid chromatography (2007) Biomed. Chromatogr, 21, pp. 747-754; Bakhtiar, R., Lohne, J., Ramos, L., Khemani, L., Hayes, M., Tse, F., High-throughput quantification of the anti-leukemia drug STI571 (Gleevec) and its main metabolite (CGP 74588) in human plasma using liquid chromatography-tandem mass spectrometry (2002) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 768, pp. 325-340; Bakhtiar, R., Khemani, L., Hayes, M., Bedman, T., Tse, F., Quantification of the anti-leukemia drug STI571 (Gleevec) and its metabolite (CGP 74588) in monkey plasma using a semi-automated solid phase extraction procedure and liquid chromatography-tandem mass spectrometry (2002) J. Pharm. Biomed. Anal, 28, pp. 1183-1194; Guetens, G., Prenen, H., De Boeck, G., Imatinib (Gleevec, Glivec) tumour tissue analysis by measurement of sediment and by liquid chromatography tandem mass spectrometry (2006) J. Sep. Sci, 29, pp. 453-459; Guetens, G., De Boeck, G., Highley, M., Dumez, H., Van Oosterom, A.T., De Bruijn, E.A., Quantification of the anticancer agent STI-571 in erythrocytes and plasma by measurement of sediment technology and liquid chromatography-tandem mass spectrometry (2003) J. Chromatogr. A, 1020, pp. 27-34; Titier, K., Picard, S., Ducint, D., Quantification of imatinib in human plasma by high-performance liquid chromatography-tandem mass spectrometry (2005) Ther. Drug Monit, 27, pp. 634-640; Luo, F.R., Barrett, Y.C., Yang, Z., Identification and validation of phospho-SRC, a novel and potential pharmacodynamic biomarker for dasatinib (SPRYCELtrade mark), a multitargeted kinase inhibitor (2008) Cancer Chemother. Pharmacol, 62, pp. 1065-1074; Rochat, B., Fayet, A., Widmer, N., Imatinib metabolite profiling in parallel to imatinib quantification in plasma of treated patients using liquid chromatography-mass spectrometry (2008) J. Mass Spectrom, 43, pp. 736-752; Parise, R.A., Ramanathan, R.K., Hayes, M.J., Egorin, M.J., Liquid chromatographic-mass spectrometric assay for quantitation of imatinib and its main metabolite (CGP 74588) in plasma (2003) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 791, pp. 39-44; Rodriguez Flores, J., Berzas Nevado, J.J., Contento Salcedo, A.M., Cabello D{\'i}az, M.P., Nonaqueous capillary electrophoresis method for the analysis of gleevec and its main metabolite in human urine (2005) J. Chromatogr. A, 1068, pp. 175-182; Rodr{\'i}guez Flores, J., Berzas, J.J., Casta{\~n}eda, G., Rodr{\'i}guez, N., Direct and fast capillary zone electrophoretic method for the determination of Gleevec and its main metabolite in human urine (2003) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 794, pp. 381-388; Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, May, 2001UR - https://www.scopus.com/inward/record.uri?eid=2-s2.0-58149263051&partnerID=40&md5=4587473cf94b1fd44c29935d2c3ce5f7",
year = "2008",
language = "English",
volume = "3",
pages = "752--760",
journal = "Pharmacologyonline",
issn = "1827-8620",
publisher = "SILAE (Italo-Latin American Society of Ethnomedicine)",

}

Imatinib quantification in rat plasma by high performance liquid chromatography with ultra violet detection - An application to preclinical pharmacokinetic study. / Shetty, R.; Kini, S.; Musmade, P.; Theerthahalli, A.; Mohan, C.; Bhat, K.M.; Patel, J.; Kumar, V.

In: Pharmacologyonline, Vol. 3, 2008, p. 752-760.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Imatinib quantification in rat plasma by high performance liquid chromatography with ultra violet detection - An application to preclinical pharmacokinetic study

AU - Shetty, R.

AU - Kini, S.

AU - Musmade, P.

AU - Theerthahalli, A.

AU - Mohan, C.

AU - Bhat, K.M.

AU - Patel, J.

AU - Kumar, V.

N1 - Export Date: 10 November 2017 Correspondence Address: Shetty, R.; Manipal College of pharmaceutical Sciences, Manipal 576 104 Udupi, Karnataka, India; email: shettyr78@gmail.com Chemicals/CAS: acetonitrile, 75-05-8; imatinib, 152459-95-5, 220127-57-1; mizolastine, 108612-45-9; phosphate, 14066-19-4, 14265-44-2 References: Druker, B.J., STI571 (Gleevec) as a paradigm for cancer therapy (2002) Trends Mol. Med, 8, pp. S14-S18; Atwell, S., Adams, J.M., Badger, J., A Novel Mode of Gleevec, Binding Is Revealed by the Structure of Spleen Tyrosine Kinase (2004) J. Biol. Chem, 279, pp. 55827-55832; Corless, C.L., Fletcher, J.A., Heinrich, M.C., Biology of Gastrointestinal Stromal Tumors (2004) J. Clin Oncol, 22, pp. 3813-3825; Leis, J.F., Primack, S.L., Schubach, S.E., Curtin, P.T., Druker, B.J., Maziarz, R.T., Management of life- threatening pulmonary leukostasis with single agent imatinib mesylate during CML myeloid blast crisis (2004) Haematologica, 89, pp. ECR30; Morishima, Y., Ogura, M., Nishimura, M., Efficacy and Safety of Imatinib Mesylate for Patients in the First Chronic Phase of Chronic Myeloid Leukemia: Results of a Japanese Phase II Clinical Study (2004) Int. J. Hematol, 80, pp. 261-266; Velpandian, T., Mathur, R., Agarwal, N.K., Arora, B., Kumar, L., Gupta, S.K., Development and validation of a simple liquid chromatographic method with ultraviolet detection for the determination of imatinib in biological samples (2004) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 804, pp. 431-434; Neville, K., Parise, R.A., Thompson, P., Plasma and cerebrospinal fluid pharmacokinetics of imatinib after administration to nonhuman primates (2004) Clin. Cancer Res, 10, pp. 2525-2529; Widmer, N., Béguin, A., Rochat, B., Determination of imatinib (Gleevec) in human plasma by solid-phase extraction-liquid chromatography-ultraviolet absorbance detection (2004) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 803, pp. 285-292; Le Coutre, P., Kreuzer, K.A., Pursche, S., (2004) Cancer Chemother. Pharmacol, 53, pp. 313-323; Oostendorp, R.L., Beijnen, J.H., Schellens, J.H., Tellingen, O., Determination of imatinib mesylate and its main metabolite (CGP74588) in human plasma and murine specimens, , by ion-pairing; reversed-phase high-performance liquid chromatography (2007) Biomed. Chromatogr, 21, pp. 747-754; Bakhtiar, R., Lohne, J., Ramos, L., Khemani, L., Hayes, M., Tse, F., High-throughput quantification of the anti-leukemia drug STI571 (Gleevec) and its main metabolite (CGP 74588) in human plasma using liquid chromatography-tandem mass spectrometry (2002) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 768, pp. 325-340; Bakhtiar, R., Khemani, L., Hayes, M., Bedman, T., Tse, F., Quantification of the anti-leukemia drug STI571 (Gleevec) and its metabolite (CGP 74588) in monkey plasma using a semi-automated solid phase extraction procedure and liquid chromatography-tandem mass spectrometry (2002) J. Pharm. Biomed. Anal, 28, pp. 1183-1194; Guetens, G., Prenen, H., De Boeck, G., Imatinib (Gleevec, Glivec) tumour tissue analysis by measurement of sediment and by liquid chromatography tandem mass spectrometry (2006) J. Sep. Sci, 29, pp. 453-459; Guetens, G., De Boeck, G., Highley, M., Dumez, H., Van Oosterom, A.T., De Bruijn, E.A., Quantification of the anticancer agent STI-571 in erythrocytes and plasma by measurement of sediment technology and liquid chromatography-tandem mass spectrometry (2003) J. Chromatogr. A, 1020, pp. 27-34; Titier, K., Picard, S., Ducint, D., Quantification of imatinib in human plasma by high-performance liquid chromatography-tandem mass spectrometry (2005) Ther. Drug Monit, 27, pp. 634-640; Luo, F.R., Barrett, Y.C., Yang, Z., Identification and validation of phospho-SRC, a novel and potential pharmacodynamic biomarker for dasatinib (SPRYCELtrade mark), a multitargeted kinase inhibitor (2008) Cancer Chemother. Pharmacol, 62, pp. 1065-1074; Rochat, B., Fayet, A., Widmer, N., Imatinib metabolite profiling in parallel to imatinib quantification in plasma of treated patients using liquid chromatography-mass spectrometry (2008) J. Mass Spectrom, 43, pp. 736-752; Parise, R.A., Ramanathan, R.K., Hayes, M.J., Egorin, M.J., Liquid chromatographic-mass spectrometric assay for quantitation of imatinib and its main metabolite (CGP 74588) in plasma (2003) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 791, pp. 39-44; Rodriguez Flores, J., Berzas Nevado, J.J., Contento Salcedo, A.M., Cabello Díaz, M.P., Nonaqueous capillary electrophoresis method for the analysis of gleevec and its main metabolite in human urine (2005) J. Chromatogr. A, 1068, pp. 175-182; Rodríguez Flores, J., Berzas, J.J., Castañeda, G., Rodríguez, N., Direct and fast capillary zone electrophoretic method for the determination of Gleevec and its main metabolite in human urine (2003) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci, 794, pp. 381-388; Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, May, 2001UR - https://www.scopus.com/inward/record.uri?eid=2-s2.0-58149263051&partnerID=40&md5=4587473cf94b1fd44c29935d2c3ce5f7

PY - 2008

Y1 - 2008

N2 - A simple and robust method for quantification of imatinib in rat plasma has been established using high performance liquid chromatography with UV detection. Mizolastine was used as an internal standard (IS). imatinib and internal standard in plasma sample were extracted using simple protein precipitation technique. The samples were injected into a C18 reverse-phase phenyl column and mobile phase used was acetonitrile - phosphate buffer (pH3.2; 25.0 mM) (24:76%, v/v) at a flow rate of 1.0 mL min-1 using ultraviolet detector. imatinib and internal standard were detected without any interference from rat plasma. Detection of imatinib in rat plasma by the high performance liquid chromatography method was accurate and precise with a quantitation limit of 20.0 ng mL-1. The proposed method was validated with linearity range of 20.0 - 10000.0 ng mL-1. Reproducibility, recovery and stability of the method were evaluated. This method has been successfully applied to pharmacokinetic evaluation of imatinib liposome formulation.

AB - A simple and robust method for quantification of imatinib in rat plasma has been established using high performance liquid chromatography with UV detection. Mizolastine was used as an internal standard (IS). imatinib and internal standard in plasma sample were extracted using simple protein precipitation technique. The samples were injected into a C18 reverse-phase phenyl column and mobile phase used was acetonitrile - phosphate buffer (pH3.2; 25.0 mM) (24:76%, v/v) at a flow rate of 1.0 mL min-1 using ultraviolet detector. imatinib and internal standard were detected without any interference from rat plasma. Detection of imatinib in rat plasma by the high performance liquid chromatography method was accurate and precise with a quantitation limit of 20.0 ng mL-1. The proposed method was validated with linearity range of 20.0 - 10000.0 ng mL-1. Reproducibility, recovery and stability of the method were evaluated. This method has been successfully applied to pharmacokinetic evaluation of imatinib liposome formulation.

M3 - Article

VL - 3

SP - 752

EP - 760

JO - Pharmacologyonline

JF - Pharmacologyonline

SN - 1827-8620

ER -