Development and validation of a method for the separation and determination of the -isomer and -demethyltamoxifen by thin-layer chromatography

World Health Organization (2025) Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed 26 Mar 2025

National Cancer Institute (2021) What is cancer? https://www.cancer.gov/about-cancer/understanding/what-is-cancer. Accessed 26 Mar 2025

World Health Organization (2024) Breast cancer. https://www.who.int/news-room/fact-sheets/detail/breast-cancer. Accessed 26 Mar 2025

Osborne CK (1998) Tamoxifen in the treatment of breast cancer. New Engl J Med 339(22):1609–1618

Article  CAS  PubMed  Google Scholar 

Robinson E, Kimmick GG, Muss HB (1996) Tamoxifen in postmenopausal women: a safety perspective. Drug Aging 5:329–337. https://doi.org/10.2165/00002512-199608050-00002

Article  Google Scholar 

Craig Jordan V (2007) New insights into the metabolism of tamoxifen and its role in the treatment and prevention of breast cancer. Steroids 13:829–842. https://doi.org/10.1016/j.steroids.2007.07.009

Article  CAS  Google Scholar 

Ahsen NV, Binder C, Brockmoller J, Oellerich M (2009) CYP2D6 and tamoxifen: pharmacogenetic reinvention of an established drug? J Lab Med 33:1–9. https://doi.org/10.1016/j.phrs.2016.03.025

Article  CAS  Google Scholar 

United States Pharmacopeial Convention (2023) tamoxifen tablets. In: USP-NF online. USP Convention, Rockville, MD. https://www.uspnf.com/. Accessed 27 Mar 2025

European Pharmacopoeia (2025) Tamoxifen citrate monograph (reference 07/2024:1046). 11th ed. Council of Europe, Strasburg, Codex: 6045–6046.

British Pharmacopoeia (2023) tamoxifen tablets. The Stationery Office. London. https://www.pharmacopoeia.com/. Accessed 27 Mar 2025

Santiago M, Strobel S (2013) Thin layer chromatography. Methods Enzymol 533:303–324. https://doi.org/10.1016/B978-0-12-420067-8.00024-6

Article  CAS  PubMed  Google Scholar 

Ferenczi-Fodor K, Végh Z, Renger B (2011) Impurity profiling of pharmaceuticals by thin-layer chromatography. J Chromatogr A 1218:2722–2731. https://doi.org/10.1016/j.chroma.2010.12.044

Article  CAS  PubMed  Google Scholar 

Lim CK, Chow LCL, Yuan ZX, Smith LL (1993) High performance liquid chromatography of tamoxifen and metabolites in plasma and tissues. Biomed Chromatogr 7:311–314. https://doi.org/10.1002/bmc.1130070606

Article  CAS  PubMed  Google Scholar 

Armstrong RD, Ward JT, Pattabiraman N, Benz C, Armstrong WD (1987) Separation of tamoxifen geometric isomers and metabolites by bonded-phase β-cyclodextrin chromatography. J Chromatogr A 414:192–196

Article  CAS  Google Scholar 

Lu W, Poon KG, Carmichael LP, Cole BR (1996) Analysis of tamoxifen and its metabolites by on-line capillary electrophoresis-electrospray ionization mass spectrometry employing nonaqueous media containing surfactants. Anal Chem 68:668–674. https://doi.org/10.1021/ac950786x

Article  CAS  PubMed  Google Scholar 

Manns JE, Hanks S, Brown JE (1998) Optimised separation of E- and Z- isomers of tamoxifen. and its principal metabolites using reversed-phase high performance liquid chromatography. J Pharm Biomed Anal 16:847–852. https://doi.org/10.1016/s0731-7085(97)00116-7

Article  CAS  PubMed  Google Scholar 

Lee K, Ward AB, Desta Z, Flockhart AD, Jones RD (2003) Quantification of tamoxifen and three metabolites in plasma by high-performance liquid chromatography with fluorescence detection: application to a clinical trial. J Chromatogr B Biomed Appl 791:245–253. https://doi.org/10.1016/s1570-0232(03)00218-6

Article  CAS  Google Scholar 

MacCallum J, Cummings J, Dixon JM, Miller WR (1996) Solid-phase extraction and high-performance liquid chromatographic determination of tamoxifen and its major metabolites in plasma. J Chromatogr B Biomed Appl 678:317–323. https://doi.org/10.1016/0378-4347(95)00530-7

Article  CAS  PubMed  Google Scholar 

Brown RR, Bain R, Jordan VC (1983) Determination of tamoxifen and metabolites in human serum by high-performance liquid chromatography with post-column fluorescence activation. J Chromatogr 272:351–358

Article  CAS  PubMed  Google Scholar 

Teunissen SF, Rosing H, Schinkel AH, Schellens JH, Beijnen JH (2010) Bioanalytical methods for determination of tamoxifen and its phase I metabolites: a review. Anal Chim Acta 683:21–37. https://doi.org/10.1016/j.aca.2010.10.009

Article  CAS  PubMed  Google Scholar 

Antunes MV, Rosa DD, Viana Tdos S, Andreolla H, Fontanive TO, Linden R (2013) Sensitive HPLC-PDA determination of tamoxifen and its metabolites N-desmethyltamoxifen, 4-hydroxytamoxifen and endoxifen in human plasma. J Pharm Biomed Anal 76:13–20. https://doi.org/10.1016/j.jpba.2012.12.005

Article  CAS  PubMed  Google Scholar 

Antunes MV, Raymundo S, De Oliveira V, Staudt DE, Gössling G, Peteffi GP, Biazús JV, Cavalheiro JA, Tre-Hardy M, Capron A, Haufroid V, Wallemacq P, Schwartsmann G, Linden R (2015) Ultra-high performance liquid chromatography tandem mass spectrometric method for the determination of tamoxifen. N-desmethyltamoxifen, 4-hydroxytamoxifen and endoxifen in dried blood spots-development. Validation and clinical application during breast cancer. Talanta 132:775–784. https://doi.org/10.1016/j.talanta.2014.10.040

Article  CAS  PubMed  Google Scholar 

Jager NG, Rosing H, Schellens JH, Beijnen JH (2014) Determination of tamoxifen and endoxifen in dried blood spots using LC-MS/MS and the effect of coated DBS cards on recovery and matrix effects. J Pharm Biomed Anal 100:254–261. https://doi.org/10.1016/j.jpba.2014.07.033

Article  CAS  Google Scholar 

Jager NG, Rosing H, Schellens JH, Beijnen JH, Linn SC (2014) Use of dried blood spots for the determination of serum concentrations of tamoxifen and endoxifen. Breast Cancer Res Treat 146:137–144. https://doi.org/10.1007/s10549-014-2999-2

Article  CAS  PubMed  Google Scholar 

Kashtiaray A, Farahani H, Farhadi S, Rochat B, Sobhi HR (2011) Trace determination of Tamoxifen in biological fluids. using hollow fiber liquid-phase microextraction followed by high-performance liquid chromatography-ultraviolet detection. Am J Anal Chem 2:429–436. https://doi.org/10.4236/ajac.2011.24052

Article  CAS  Google Scholar 

Peris-Vicente J, Ochoa-Aranda E, Bose D, Esteve-Romero J (2015) Determination of tamoxifen and its main metabolites in plasma samples from breast cancer patients by micellar liquid chromatography. Talanta 131:535–540. https://doi.org/10.1016/j.talanta.2014.07.093

Article  CAS  PubMed  Google Scholar 

Adam HK, Douglas EJ, Kemp JV (1979) The metabolism of tamoxifen in human. Biochem Pharmacol 28:145–147. https://doi.org/10.1016/0006-2952(79)90283-1

Article  CAS  PubMed  Google Scholar 

Adam HK, Gay MA, Moore RH (1980) Measurement of tamoxifen in serum by thin-layer densitometry. J Endocrinol 84:35–42. https://doi.org/10.1677/joe.0.0840035

Article  CAS  PubMed  Google Scholar 

International Council for Harmonisation (2023) ICH Q2(R2) Guideline on validation of analytical procedures. https://database.ich.org/sites/default/files/ICH_Q2%28R2%29_Guideline_2023_1130.pdf. Accessed 26 Mar 2025

Comments (0)

No login
gif