Haque SM, Ratemi ES (2017) Drug development and analysis review. Pharm Chem J 50:837–850
Geiser K (2006) Making safer chemicals. In: Abraham MA (ed) Sustainability science and engineering. Elsevier, Amsterdam, pp 161–175
Shewiyo DH, Kaale EA, Risha PG, Dejaegher B, Smeyers-Verbeke J, Vander Heyden Y (2012) HPTLC methods to assay active ingredients in pharmaceutical formulations: a review of the method development and validation steps. J Pharm Biomed Anal 66:11–23
Zlatkis A, Kaiser RE (2011) HPTLC—High performance thin-layer chromatography. Elsevier, Amsterdam
Ferguson P, Raynie D (2018) Green analytical chemistry. In: Zhang W, Cue BW (eds) Green techniques for organic synthesis and medicinal chemistry. John Wiley & Sons, Hoboken, pp 43–70
Ibrahim AE, El Deeb S, Abdellatef HE, Hendawy HA, El-Abassy OM, Ibrahim H (2022) Eco-friendly and sensitive HPLC and TLC methods validated for the determination of betahistine in the presence of its process-related impurity. Separations 9(2):32–49
Tome T, Žigart N, Časar Z, Obreza A (2019) Development and optimization of liquid chromatography analytical methods by using AQbD principles: overview and recent advances. Org Process Res Dev 23(9):1784–1802
Yu LX (2008) Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res J 25:781–791
Rozet E, Lebrun P, Michiels JF, Sondag P, Scherder T, Boulanger B (2015) Analytical procedure validation and the quality by design paradigm. J Biopharm Stat 25(2):260–268
González O, Blanco ME, Iriarte G, Bartolomé L, Maguregui MI, Alonso RM (2014) Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect. J Chromatogr A 1353:10–27
Silveira GD, Pego AM, Pereira e Silva J, Yonamine M (2019) Green sample preparations for the bioanalysis of drugs of abuse in complex matrices. Bioanalysis 11(04):295–312
Swartz ME, Krull IS (2012) Handbook of analytical validation. CRC Press, Boca Raton
Vijayakumar B, Suman E, Sreekanth G (2016) Estimation of crizotinib in capsule dosage form by RP-HPLC. IOSR J Pharm Biol Sci 11:93–103
Wei LM, Xu ZX, Lv PF, Xue YL, Wang XX, Zhang M (2016) A simple HPLC method for the determination of Ibrutinib in rabbit plasma and its application to a pharmacokinetic study. Lat Am J Pharm 35(1):134–145
Suneetha A, Donepudi S (2017) HPLC method development and validation for the estimation of Axitinib in rabbit plasma. Braz J Pharm Sci 53:1–12
Dziadosz M, Lessig R, Bartels H (2012) HPLC–DAD protein kinase inhibitor analysis in human serum. J Chromatogr B 893:77–81
Wasnik U, Lakade S, Harde M, Banduke M, Dighe T, More A, Nale P, Patange A, Waghmare S, Kharsade D (2023) Green HPTLC-densitometric approach for quantitation of Ruxolitinib in bulk and marketed formulation. Res J Pharm Technol 16(9):4219–4224
Fouad M, Helvenstein M, Blankert B (2015) Ultra high performance liquid chromatography method for the determination of two recently FDA approved TKIs in human plasma using diode array detection. J Anal Methods Chem 2015:213–231
Merienne C, Rousset M, Ducint D, Castaing N, Titier K, Molimard M, Bouchet S (2018) High throughput routine determination of 17 tyrosine kinase inhibitors by LC–MS/MS. J Pharm Biomed Anal 150:112–120
Ni MW, Zhou J, Li H, Chen W, Mou HZ, Zheng ZG (2017) Simultaneous determination of six tyrosine kinase inhibitors in human plasma using HPLC-Q-Orbitrap mass spectrometry. Bioanalysis 9(12):925–935
Koller D, Vaitsekhovich V, Mba C, Steegmann JL, Zubiaur P, Abad-Santos F, Wojnicz A (2020) Effective quantification of 11 tyrosine kinase inhibitors and caffeine in human plasma by validated LC-MS/MS method with potent phospholipids clean-up procedure. Appl Therap Drug Monit Talanta 208:120450
Bellouard M, Donadieu J, Thiebot P, Giroux Leprieur E, Saiag P, Etting I, Dugues P, Abe E, Alvarez JC, Larabi IA (2023) Validation of liquid chromatography coupled with tandem mass spectrometry for the determination of 12 tyrosine kinase inhibitors (TKIs) and their application to therapeutic drug monitoring in adult and pediatric populations. Pharmaceutics 16(1):1–5
Charlier B, Marino L, Dal Piaz F, Pingeon M, Coglianese A, Izzo B, Serio B, Selleri C, Filippelli A, Izzo V (2019) Development and validation of a reverse-phase high-performance liquid chromatography with fluorescence detection (RP-HPLC-FL) method to quantify ruxolitinib in plasma samples. Anal Lett 52(8):1328–1339
Petr J (2023) Determination of tyrosine kinase inhibitors via capillary electrophoresis with tandem mass spectrometry and online stacking preconcentration. Pharmaceuticals 16(2):186–197
PubMed PubMed Central CAS Google Scholar
Ahmed O (2019) Contribution of capillary electrophoresis for the therapeutic drug monitoring of patients treated by targeted cancer therapy: application to tyrosine kinase inhibitors. Université Montpellier
Darwish IA, Khalil NY, Darwish HW, Alzoman NZ, Al-Hossaini AM (2021) Spectrophotometric and computational investigations of charge transfer complexes of chloranilic acid with tyrosine kinase inhibitors and application to development of novel universal 96-microwell assay for their determination in pharmaceutical formulations. Spectrochim Acta A Mol Biomol Spectrosc 252:119482
Guo ZX, Wu YE, Shi HY, van den Anker J, Liang P, Zheng Y, Zhao XW, Feng R, Zhao W (2023) A liquid chromatography-tandem mass spectrometry method for simultaneous quantification of thirty-nine tyrosine kinase inhibitors in human plasma. J Pharm Biomed Anal 224:115159
Lou Y, Qin H, Hu Q, Chai Y, Zhou H, Chen M, Wang Q, Huang P, Gu J, Zhang Y (2022) Development and validation of a novel LC-MS/MS method for simultaneous quantitative determination of tyrosine kinase inhibitors in human plasma. J Chromatogr B 1208:123394
Verougstraete N, Stove V, Verstraete AG, Stove C (2021) Quantification of eight hematological tyrosine kinase inhibitors in both plasma and whole blood by a validated LC-MS/MS method. Talanta 226:122140
Ezzeldin E, Iqbal M, Herqash RN, ElNahhas T (2020) Simultaneous quantitative determination of seven novel tyrosine kinase inhibitors in plasma by a validated UPLC-MS/MS method and its application to human microsomal metabolic stability study. J Chromatogr B 1136:121851
Mackey TK, Liang BA (2013) Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHO-Interpol trilateral mechanism. BMC Med 11:1–10
Fink C, Sun D, Wagner K, Schneider M, Bauer H, Dolgos H, Mäder K, Peters SA (2020) Evaluating the role of solubility in oral absorption of poorly water-soluble drugs using physiologically-based pharmacokinetic modeling. Clin Pharmacol Ther 107(3):650–661
Appeldoorn TY, Munnink TO, Morsink LM, Hooge ML, Touw DJ (2023) Pharmacokinetics and pharmacodynamics of ruxolitinib: a review. Clin Pharmacokinet 62(4):559–571
PubMed PubMed Central CAS Google Scholar
Akbel E, Güngör S, Bulduk İ (2022) Alternative analytical methods for ibrutinib quantification in pharmaceutical formulation: a statistical comparison. Rev Anal Chem 41(1):146–157
Guideline IHT (2013) Validation of analytical procedures: text and methodology, q2 (r1) the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Geneva.
Darwish IA, Khalil NY, AlZeer M (2020) ICH/FDA guidelines-compliant validated stability-indicating HPLC-UV method for the determination of Axitinib in bulk and dosage forms. Curr Anal Chem 16(8):1106–1112
Ashok G, Mondal S, Ganapaty S, Bandla J (2018) Development and validation of stability indicating method for the estimation of pazopanib hydrochloride in pharmaceutical dosage forms by RP-HPLC. Pharm Lett 7(12):234–241
Heigener DF, Reck M (2018) Crizotinib. In: Martens UM (ed) Small molecules in oncology. Springer, Berlin, pp 57–65
Mead AJ, Milojkovic D, Knapper S, Garg M, Chacko J, Farquharson M, Yin J, Ali S, Clark RE, Andrews C, Dawson MK (2015) Response to ruxolitinib in patients with intermediate-1–, intermediate-2–, and high-risk myelofibrosis: results of the UK ROBUST Trial. Br J Haematol 170(1):29–39
Koradia S, Patel M, Sen AK, Sen DB, Pradhan P (2024) Analytical quality by design-based thin-layer chromatography method development and validation for assay and content uniformity testing of the anti-neoplastic drug Axitinib in tablet formulation. Sep Sci Plus 7(3):2300176
Ghode PD, Dhaigude PU, Rathod SP, Sayare AS, Pachauri AD, Khandelwal K, Ghode SP (2020) Stability indicating HPTLC method development and validation for the estimation of pazopanib hydrochloride in bulk and its dosage form. Int J Pharm Res 12(3):1–19
Mukai Y, Wakamoto A, Hatsuyama T, Yoshida T, Sato H, Fujita A, Toda T (2021) An liquid chromatography–tandem mass spectrometry method for the simultaneous determination of afatinib, alectinib, ceritinib, crizotinib, dacomitinib, erlotinib, gefitinib, and osimertinib in human serum. Ther Drug Monit 43(6):772–779
Shah DA, Patel JM, Mahajan A, Chhalotiya U (2021) Thin layer chromatographic method for separation and estimation of anticancer drug Ibrutinib in presence of its degradants. Sep Sci Plus 4(8):314–322
Pena Pereira F, Wojnowski W, Tobiszewski M (2020) AGREE—Analytical GREEnness metric approach and software. Anal Chem 92(14):10076–10082
PubMed PubMed Central CAS Google Scholar
Gałuszka A, Migaszewski ZM, Konieczka P, Namieśnik J (2012) Analytical eco-scale for assessing the greenness of analytical procedures. Trends Anal Chem 37:61–72
Moffid MA, Mahmoud ST, Sayed RM (2023) An eco-friendly ultra-performance liquid chromatography–mass spectrometry method for quantification of rivaroxaban and ticagrelor in rat plasma: grapefruit interactions. Bioanalysis 15(22):1327–1341
Comments (0)