Central composite design-assisted development and validation of a stability-indicating instrumental thin-layer chromatography method for the quantification of itraconazole in tablet dosage form using BAGI and GAPI tools

Cowen LE, Sanglard D, Howard SJ et al (2015) Mechanisms of antifungal drug resistance. Cold Spring Harb Perspect Med 5(7):a019752. https://doi.org/10.1101/CSHPERSPECT.A019752

Article  PubMed Central  Google Scholar 

Herrick EJ, Patel P, Hashmi MF, (2024) Antifungal Ergosterol Synthesis Inhibitors. StatPearls Publishing Islands

Strating JRPM, van der Linden L, Albulescu L et al (2015) Itraconazole inhibits enterovirus replication by targeting the oxysterol-binding protein. Cell Rep 10:600–615. https://doi.org/10.1016/j.celrep.2014.12.054

Article  CAS  PubMed  PubMed Central  Google Scholar 

Xie S, Zhu X, Gao N et al (2023) Genetic variations of CYP3A4 on the metabolism of itraconazole in vitro. Food Chem Toxicol 181:114101. https://doi.org/10.1016/j.fct.2023.114101

Article  CAS  PubMed  Google Scholar 

Liesenborghs L, Spriet I, Jochmans D et al (2021) Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial. EBioMedicine 66:103288. https://doi.org/10.1016/J.EBIOM.2021.103288

Article  CAS  PubMed  PubMed Central  Google Scholar 

Shenoy M, Dhoot D, Mahajan H, Barkate H (2021) An open-label, randomized, double-arm clinical trial to compare the effectiveness and safety of super bioavailable itraconazole capsules and itraconazole capsules in the management of dermatophytosis in India. Clin Cosmet Investig Dermatol 14:1367. https://doi.org/10.2147/CCID.S326642

Article  PubMed  PubMed Central  Google Scholar 

Heykants J, Van Peer A, Van de Velde V et al (1989) The clinical pharmacokinetics of itraconazole: an overview. Mycoses 32:67–87. https://doi.org/10.1111/J.1439-0507.1989.TB02296.X

Article  PubMed  Google Scholar 

Chen L, Zhang Y, Zhang YX et al (2024) Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring. J Pharm Anal 14:100899. https://doi.org/10.1016/J.JPHA.2023.11.006

Article  PubMed  Google Scholar 

Rifai N, Sakamoto M, Platt O, Brugnara C (1995) A high-performance liquid chromatographic assay for the determination of itraconazole concentration using solid-phase extraction and small sample volume. Ther Drug Monit 17:522–525. https://doi.org/10.1097/00007691-199510000-00014

Article  CAS  PubMed  Google Scholar 

Hafez HM, Barghash SS, Soliman MM, et al. (2023) Central composite design driven optimization of sustainable stability indicating HPLC method for the determination of Tigecycline and greenness assessment. F1000Research https://doi.org/10.12688/f1000research.130861.2

Rahman A, Aqil M, Ahad A et al (2021) Application of central composite design for the optimization of itraconazole loaded nail lacquer formulation. 3 Biotech 11(7):324. https://doi.org/10.1007/S13205-021-02862-0

Article  PubMed  PubMed Central  Google Scholar 

Sangshetti JN, Deshpande M, Zaheer Z et al (2017) Quality by design approach: regulatory need. Arab J Chem 10:S3412–S3425. https://doi.org/10.1016/J.ARABJC.2014.01.025

Article  CAS  Google Scholar 

Prajapati P, Tamboli J, Surati P, Mishra A (2021) Risk assessment-based enhanced analytical quality by design approach to eco-friendly and economical multicomponent spectrophotometric methods for simultaneous estimation of montelukast sodium and bilastine. J AOAC Int 104:1453–1463. https://doi.org/10.1093/jaoacint/qsab089

Article  PubMed  Google Scholar 

Prajapati PB, Patel UR, Shah SA (2022) Fractional factorial and central composite design for implementation of risk and DoE-based enhanced AQbD approach to eco-friendly HPTLC method for estimation of dalfampridine in pharmaceutical dosage forms and human plasma. J Iran Chem Soc 19:2263–2277. https://doi.org/10.1007/S13738-021-02445-Z

Article  CAS  Google Scholar 

Mevada S, Shukla S, Patel H (2024) Simultaneous estimation of andrographolide, apigenin, apocynin, and gallic acid by high-performance thin layer chromatography method with greenness quality by design approach. Sep Sci PLUS 7:2300109. https://doi.org/10.1002/SSCP.202300109

Article  CAS  Google Scholar 

Manousi N, Wojnowski W, Płotka-Wasylka J, Samanidou V (2023) Blue applicability grade index (BAGI) and software: a new tool for the evaluation of method practicality. Green Chem 25:7598–7604. https://doi.org/10.1039/D3GC02347H

Article  CAS  Google Scholar 

Mevada S, Shukla S, U Patel H (2025) Greenness assessment of high-performance liquid chromatography method for simultaneous estimation of apigenin, apocynin, and gallic acid with quality by design approach. Sep Sci PLUS 8:e202400335. https://doi.org/10.1002/SSCP.202400335

Article  CAS  Google Scholar 

Mevada S, Patel H, Shukla S (2024) Simultaneous equation method for the estimation of gallic acid and apigenin by UV–visible spectrophotometry. Accredit Qual Assur 29:11–17. https://doi.org/10.1007/S00769-023-01558-7

Article  CAS  Google Scholar 

Mevada S, Patel H, Shukla S, (2025) Development and validation of simultaneous equation method for the estimation of andrographolide and apocynin in hepatoprotective polyherbal formulation using UV–visible spectrophotometry. Accredit Qual Assur https://doi.org/10.1007/S00769-025-01633-1/METRICS

Parikh SK, Dave JB, Patel CN, Ramalingan B (2011) Stability-indicating high-performance thin-layer chromatographic method for analysis of itraconazole in bulk drug and in pharmaceutical dosage form. Pharm Methods 2:88–94. https://doi.org/10.4103/2229-4708.84442

Article  PubMed  PubMed Central  Google Scholar 

Mirza MA, Talegaonkar S, Iqbal Z (2012) Quantitative analysis of itraconazole in bulk, marketed, and nano formulation by validated, stability indicating high performance thin layer chromatography. J Liq Chromatogr Relat Technol 35:1459–1480. https://doi.org/10.1080/10826076.2011.619037

Article  CAS  Google Scholar 

Breadmore MC, Procházková A, Theurillat R, Thormann W (2003) Determination of itraconazole and hydroxyitraconazole in human serum and plasma by micellar electrokinetic chromatography. J Chromatogr A 1014:57–70. https://doi.org/10.1016/S0021-9673(03)00573-9

Article  CAS  PubMed  Google Scholar 

Wong JW, Nisar UR, Yuen KH (2003) Liquid chromatographic method for the determination of plasma itraconazole and its hydroxy metabolite in pharmacokinetic/bioavailability studies. J Chromatogr B Anal Technol Biomed Life Sci 798:355–360. https://doi.org/10.1016/j.jchromb.2003.09.059

Article  CAS  Google Scholar 

Dwivedi A, Singh B, Sharma S et al (2014) Ultra-performance liquid chromatography electrospray ionization-tandem mass spectrometry method for the simultaneous determination of itraconazole and hydroxy itraconazole in human plasma. J Pharm Anal 4:316–324. https://doi.org/10.1016/j.jpha.2013.09.005

Article  CAS  PubMed  Google Scholar 

Cox SK, Orosz S, Burnette J, Frazier D (1997) Microassay for determination of itraconazole and hydroxyitraconazole in plasma and tissue biopsies. J Chromatogr B Biomed Sci Appl 702:175–180. https://doi.org/10.1016/S0378-4347(97)00378-2

Article  CAS  PubMed  Google Scholar 

Singh S, Bhandole A, Devendra Lodhi D (2021) Review on analytical methods for estimation of itraconazole in bulk and pharmaceutical dosage form. Int J Res Rev 8:30–37. https://doi.org/10.52403/IJRR.20210506

Article  Google Scholar 

Naik AV, Sellappan K (2020) Chromatographic fingerprint of essential oils in plant organs of Annona muricata L. (Annonaceae) using HPTLC. Anal Chem Lett 10:214–226. https://doi.org/10.1080/22297928.2020.1763197

Article  CAS  Google Scholar 

Urvisha P, Nisha P, Ragin S, Arpit P (2020) Novel stability-indicating high-performance thin layer chromatography (HPTLC) method development and validation for estimation of daclatasvir dihydrochloride in pharmaceutical dosage form. Anal Chem Lett 10:402–413. https://doi.org/10.1080/22297928.2020.1779812

Article  CAS  Google Scholar 

Vyas AJ, Gol DA, Usdad RG et al (2020) HPTLC-densitometric method for simultaneous estimation of olmesartan medoxomil and chlorthalidone in tablet dosage form. Anal Chem Lett 10:498–506. https://doi.org/10.1080/22297928.2020.1814859

Article  CAS  Google Scholar 

Kalwar PR, Kolte SS, Thaker K (2021) Identification of progesterone in the banana inflorescence of Musa paradisiaca L. species by using HPTLC and GC-MS techniques. Anal Chem Lett 11:39–54. https://doi.org/10.1080/22297928.2021.1876574

Article  CAS  Google Scholar 

Sharma A, Gaurav K, Srivastava R (2021) A comparative estimation of Alprazolam in pharmaceutical formulations by validated HPLC and HPTLC techniques. Anal Chem Lett 11:187–197. https://doi.org/10.1080/22297928.2021.1892520

Article  CAS  Google Scholar 

Meshram D, Bagade S (2007) High Performance Thin Layer Chromatographic Estimation of Itraconazole in Capsules.J. of Pharma. Res. 6: 205–207. https://www.researchgate.net/publication/236209233_High_Performance_Thin_Layer_Chromatographic_Estimation_of_Itraconazole_in_Capsules.

Yadav PN, Chhalotiya UK, Kachhiya HM et al (2021) Quantification of β-adrenergic receptor agonist drug Mirabegron in presence of degradants by high performance thin layer chromatography. Anal Chem Lett 11:512–522.

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