Novel eco-friendly HPTLC method using dual-wavelength detection for simultaneous quantification of duloxetine and tadalafil with greenness evaluation and application in human plasma.
Dual-wavelength
Duloxetine
Greenness evaluation
HPTLC-Densitometry
Human plasma
Tadalafil
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
13 Oct 2024
13 Oct 2024
Historique:
received:
25
01
2024
accepted:
18
09
2024
medline:
14
10
2024
pubmed:
14
10
2024
entrez:
13
10
2024
Statut:
epublish
Résumé
A novel, environmentally friendly, and sensitive HPTLC method has been developed and validated for simultaneous quantification of duloxetine (DLX) and tadalafil (TDL) in their pure state, laboratory-prepared mixtures, and spiked human plasma. This method is particularly important for patients dealing with depression and sexual issues, as it allows for the measurement of these co-administered antidepressant and sexual stimulant drugs in biological fluids. The separation process employed a stationary phase of pre-coated silica gel 60 F
Identifiants
pubmed: 39397048
doi: 10.1038/s41598-024-73523-4
pii: 10.1038/s41598-024-73523-4
doi:
Substances chimiques
Tadalafil
742SXX0ICT
Duloxetine Hydrochloride
9044SC542W
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
23907Informations de copyright
© 2024. The Author(s).
Références
Patel, S. K. et al. Validation of a stability-indicating HPTLC method for analysis of duloxetine hydrochloride in capsule dosage form. Separation and analysis of duloxetine hydrochloride and olanzapine in a synthetic mixture. JPC–Journal Planar Chromatogr. TLC. 22, 121–126 (2009).
doi: 10.1556/JPC.22.2009.2.8
Dhaneshwar, S. S., Deshpande, P., Patil, M., Vadnerkar, G. & Dhaneshwar, S. R. Development and validation of a HPTLC method for estimation of duloxetine hydrochloride in bulk drug and in tablet dosage form. Indian J. Pharm. Sci. 70, 233 (2008).
pubmed: 20046720
pmcid: 2792489
doi: 10.4103/0250-474X.41463
Samal, L. & Prusty, A. Development and validation of Uv-Visible Spectrophotometric Method for determination of Duloxetine. Int. J. Pharm. Pharm. Sci. 11, 27–31 (2019).
doi: 10.22159/ijpps.2019v11i3.30981
Abdelhamid, N. S., Naguib, I. A., Anwar, B. H. & Magdy, M. A. A validated HPTLC method for the quantitative determination of duloxetine hydrochloride and 1-naphthol in bulk and pharmaceutical formulation. J. Planar Chromatogr. - Mod. TLC. 33, 391–396 (2020).
doi: 10.1007/s00764-020-00045-w
Knadler, M. P., Lobo, E., Chappell, J. & Bergstrom, R. Duloxetine: Clinical pharmacokinetics and drug interactions. Clin. Pharmacokinet. 50, 281–294 (2011).
Abu-hassan, A. A., Derayea, S. M. & Ali, R. Abu-hassan, A. A. two facile approaches based on association complex with erythrosine-B for nano-level analysis of duloxetine: application to content uniformity. R Soc. Open. Sc. 8, 210922 (2021).
doi: 10.1098/rsos.210922
Raj, V. A., Ramesh, R., Phani Kumar & T. & A. A validated UV spectrophotometric determination of an antidepressant drug - duloxetine hydrochloride from capsule formulations. Int. J. Pharma Bio Sci. 2, 716–720 (2011).
Kamila, M. M., Mondal, N. & Ghosh, L. K. A validated UV spectrophotometric method for determination of duloxetine hydrochloride. Die Pharm. Int. J. Pharm. Sci. 62, 414–415 (2007).
Yunoos, M., Sankar, D. G., Kumar, B. P., Hameed, S. & Hussain, A. Simple UV spectrophotometric determination of duloxetine hydrochloride in bulk and in pharmaceutical formulations. E-J. Chem. 7, 785–788 (2010).
Alarfaj, N. A., Ammar, R. A. & El-Tohamy, M. F. Cationic-enhanced spectrofluorimetric method for determination of selective serotonin reuptake inhibitor duloxetine hydrochloride in its dosage forms. Asian J. Chem. 25, 6416–6420 (2013).
doi: 10.14233/ajchem.2013.15035
Lakshmana Prabu, S., Shahnawaz, S., Dinesh Kumar, C., Vasantharaju, S. G. & Abraham, J. Spectrofluorimetric method for determination of tramadol hydrochloride in bulk and pharmaceutical dosage forms. Indian Drugs. 46, 32–34 (2009).
Sagirli, O., Toker, S. E. & Önal, A. Development of sensitive spectrofluorimetric and spectrophotometric methods for the determination of duloxetine in capsule and spiked human plasma. Luminescence. 29, 1014–1018 (2014).
pubmed: 24619645
doi: 10.1002/bio.2652
Abd-AlGhafar, W. N., Shabana, A., El‐Shaheny, R., Tolba, M. M. & R. & Environmentally benign first derivative synchronous spectrofluorimetry for the analysis of two binary mixtures containing duloxetine with avanafil or tadalafil in spiked plasma samples. Luminescence. 39, e4696 (2024).
pubmed: 38494193
doi: 10.1002/bio.4696
Pushpalatha, P. et al. Determination of free duloxetine in human serum by high-performance thin-layer chromatography. JPC–Journal Planar Chromatogr. TLC. 26, 354–357 (2013).
doi: 10.1556/JPC.26.2013.4.11
Derayea, S. M., Elhamdy, H. A., Oraby, M. & El-Din, K. M. B. Simultaneous measurement of duloxetine hydrochloride and avanafil at dual-wavelength using novel ecologically friendly TLC-densitometric method: application to synthetic mixture and spiked human plasma with evaluation of greenness and blueness. BMC Chem. 18, 1–13 (2024).
doi: 10.1186/s13065-024-01195-2
Ammar, R. A., Otaif, H. & Al-Warthan, A. A novel ion-selective membrane electrode for the determination of duloxetine. Anal. Methods. 4, 1427–1431 (2012).
doi: 10.1039/c2ay05884g
Al-Qahtani, S. D. Potentiometric determination of Duloxetine Hydrochloride using coated Wire Electrode in pure and Pharmaceutical preparations. Asian J. Pharm. 11, S854–S857 (2017).
Alarfaj, N. A., Ammar, R. A., El-Tohamy, M. F. & Retraction Disposable screen-printed sensors for determination of Duloxetine Hydrochloride. Chem. Cent. J. 6, 2–9 (2012).
Hassanein, A. M., Moharram, Y. I., Oraiby, N. F. & Ebied, S. E. Trace determination of duloxetine HCl in formulation and spiked human serum at a carbon paste electrode. Am. J. Anal. Chem. 8, 708–725 (2017).
doi: 10.4236/ajac.2017.811052
Thejaswini, J., Gurupadayya, B. & Ranjith, K. K. Quantitative determination of duloxetine HCL in human plasma by GC-FID method. Int. J. Pharm. Pharm. Sci. 5, 405–408 (2013).
Srinivasulu, P., Srinivas, K. S. V., Reddy, R. S. & Mukkanti, K. & Buchireddy, R. A validated stability indicating rapid LC method for duloxetine HCl. 64, 1–4 (2009).
Boopathy, D., Jawarkar, R. D., Prakash, M., Mathew, B. & Perumal, P. New RP-HPLC method development and validation determination for estimation of duloxetine HCl in enteric coated capsules. Int. J. Chem. Tech. Res. 2, 239–241 (2010).
Chhalotiya, U. K., Bhatt, K. K., Shah, D. A. & Baldania, S. L. Development and validation of a stability-indicating RP-HPLC method for duloxetine hydrochloride in its bulk and tablet dosage form. Sci. Pharm. 78, 857–868 (2010).
pubmed: 21179321
pmcid: 3007604
doi: 10.3797/scipharm.1009-11
Sinha, V. R., Kumria, R. & Bhinge, J. R. Stress degradation studies on duloxetine hydrochloride and development of an RP-HPLC method for its determination in capsule formulation. J. Chromatogr. Sci. 47, 589–593 (2009).
pubmed: 19772733
doi: 10.1093/chromsci/47.7.589
Nesalin, J. A. J. & Babu, C. J. G. Validated Extractive Spectrophotometric Estimation of Tadalafil in Tablet Dosage Form. 6, 611–614 (2009).
Abdel-raoof, A. M., Abdel-fattah, A. & Madkour, A. W. Simultaneous determination of citalopram and tadalafil by the second derivative synchronous fluorescence method in biological fluids; application of box – behnken optimization design. 57–65 (2021).
Naguib, I. A., Magdy, M. A., Anwar, B. H. & Abdelhamid, N. S. A validated Green HPTLC Method for quantitative determination of Dapoxetine Hydrochloride and Tadalafil in Bulk and Pharmaceutical formulations. 58, 303–308 (2020).
Pradesh, A. UV Spectrophotometric Method for the estimation of Tadalafil in Bulk and Tablet Dosage form. 7, 833–836 (2010).
Abu, M. et al. Validated spectrofluorimetric method for determination of two phosphodiesterase inhibitors tadalafil and vardenafil in pharmaceutical preparations and spiked human plasma. 173–178 (2016).
Patel, S. A. & Patel, N. J. High performance thin layer chromatographic method for determination of tadalafil in tablet dosage form. Am. J. PharmTech Res. 1, 138–146 (2011).
Rezk, M. R., Tantawy, M. A., Wadie, M. & Weshahy, S. A. Smart spectrophotometric assessment of tamsulosin hydrochloride and tadalafil in their new pharmaceutical formulation for treatment of benign prostatic hyperplasia and erectile dysfunction. Spectrochim Acta Part. Mol. Biomol. Spectrosc. 117547 (2019).
Lakshmi, V. N. & Kumar, D. R. Validated spectrophotometric methods for the determination of Tadalafil in pharmaceutical formulations. 25, 791–794 (2009).
Elama, H. S. & Shereen, M. A synchronous spectrofluorometric technique for simultaneous detection of alfuzosin and tadalafil: applied to tablets and spiked biological samples. (2022).
Abdel-raoof, A. M. et al. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy D-optimal design as a useful tool response surface methodology for the optimization of signals from synchronous fl uorescence prior to simultaneous determination of avana fi l and tadala. Spectrochim Acta Part. Mol. Biomol. Spectrosc. 235, 118313 (2020).
doi: 10.1016/j.saa.2020.118313
Rezk, M. R., Abdel-Moety, E. M., Wadie, M. & Tantawy, M. A. Stability assessment of tamsulosin and tadalafil co-formulated in capsules by two validated chromatographic methods. J. Sep. Sci. 44, 530–538 (2021).
pubmed: 33207075
doi: 10.1002/jssc.202000975
Tantawy, M. A., Weshahy, S. A., Wadie, M. & Rezk, M. R. Novel HPTLC densitometric methods for determination of tamsulosin HCl and tadalafil in their newly formulated dosage form: comparative study and green profile assessment. Biomed. Chromatogr. 34, 1–12 (2020).
doi: 10.1002/bmc.4850
Tampubolon, H. B. et al. Densitometric Determination of Tadalafil Citrate in tablets: validation of the Method. 29, 2753–2765 (2006).
Causanilles, A., Emke, E. & de Voogt, P. Determination of phosphodiesterase type V inhibitors in wastewater by direct injection followed by liquid chromatography coupled to tandem mass spectrometry. Sci. Total Environ. 565, 140–147 (2016).
pubmed: 27161135
doi: 10.1016/j.scitotenv.2016.04.158
Patel, J. K. & Patel, N. K. Stability-indicating RP-HPLC method for the determination of ambrisentan and tadalafil in pharmaceutical dosage form. Sci. Pharm. 82, 749–764 (2014).
pubmed: 26279975
pmcid: 4500576
doi: 10.3797/scipharm.1403-22
Bojanapu, A. et al. Validation and method development of tadalafil in bulk and tablet dosage form by RP-HPLC. Drug Res. (Stuttg) 82–85 (2014).
Dogan, A. & Basci, E. Green bioanalytical and pharmaceutical analysis of voriconazole and tadalafil by HPLC. Curr. Pharm. Anal. 13, 495–504 (2017).
doi: 10.2174/1573412913666170210160251
Aboul-Enein, H. Y. & Ali, I. Determination of tadalafil in pharmaceutical preparation by HPLC using monolithic silica column. Talanta. 65, 276–280 (2005).
pubmed: 18969796
doi: 10.1016/j.talanta.2004.06.012
Sartori, E. R., Clausen, D. N., Matheus, I. & Pires, R. & Salamanca-neto, C. A. R. PT NU SC. Diam. Relat. Mater. (2017).
Demir, E., Inam, R., Ozkan, S. A. & Uslu, B. Electrochemical behavior of tadalafil on TiO 2 nanoparticles – MWCNT composite paste electrode and its determination in pharmaceutical dosage forms and human serum samples using adsorptive stripping square wave voltammetry. 2709–2720 (2014).
Oliveira, F. M., De, Ferreira, P. A., Neves, C. G. & Rosa, T. M. Fast screening and determination of Tadalafil in Pharmaceutics by Batch Injection Analysis (BIA) with Amperometric Detection. 2253–2259 (2020).
Zambianco, N. A. et al. Determination of tadala fi l in pharmaceutical samples by vertically oriented multi-walled carbon nanotube electrochemical sensing device. J. Electroanal. Chem. 877, 114501 (2020).
doi: 10.1016/j.jelechem.2020.114501
Yang, L., Zhao, H., Li, C., Fan, S. & Li, B. Biosensors and Bioelectronics Dual β -cyclodextrin functionalized au @ SiC nanohybrids for the electrochemical determination of tadala fi l in the presence of acetonitrile. Biosens. Bioelectron. 64, 126–130 (2015).
pubmed: 25216449
doi: 10.1016/j.bios.2014.08.068
Ali, I. Validated Method for Tadalafil Analysis in Pharmaceutical preparations by Capillary Electrophoresis. 187–191 (2004).
Higgins, A. Antidepressant-associated sexual dysfunction: impact, effects, and treatment. 141–150 (2010).
Fenske, M. Determination of Cortisol in Human plasma by thin-layer chromatography and fluorescence derivatization with Isonicotinic Acid Hydrazide. 46, 4–6 (2008).
Rezk, M. R., Monir, H. H. & Marzouk, H. M. Novel determination of a new antiviral combination; sofosbuvir and velpatasvir by high performance thin layer chromatographic method ; application to real human samples. Microchem J. 146, 828–834 (2019).
doi: 10.1016/j.microc.2019.02.012
Rits, I. A. Declaration of Helsinki. Recommendations guidings doctors in clinical research. World Med. J. 11, 281 (1964).
pubmed: 14182999
Conference, I. et al. Requirements for registration of pharmaceuticals for human ich h armonised t ripartite g uideline v alidation of a nalytical p rocedures: Parent Guideline : Text on Validation of Analytical Procedures. (2005). (1994).
Forgue, S. T. et al. Tadalafil pharmacokinetics in healthy subjects Correspondence. (2005).
Wadie, M., Abdel-moety, E. M., Rezk, M. R. & Marzouk, H. M. A novel eco-friendly HPLC method with dual detection modes for versatile quantification of dutasteride and silodosin in pharmaceutical formulation, dissolution testing and spiked human plasma. Microchem J. 197, 109753 (2024).
doi: 10.1016/j.microc.2023.109753
Rostom, Y. et al. Molecular and Biomolecular Spectroscopy State-of-the-Art mathematically induced filtration approaches for smart spectrophotometric assessment of silodosin and solifenacin mixture in their new challenging formulation : Multi-to. Spectrochim Acta Part. Mol. Biomol. Spectrosc. 307, 123650 (2024).
doi: 10.1016/j.saa.2023.123650
Keith, L. H., Gron, L. U. & Young, J. L. Green analytical methodologies. Chem. Rev. 107, 2695–2708 (2007).
pubmed: 17521200
doi: 10.1021/cr068359e
Derayea, S. M., Elhamdy, H. A., El-din, K. M. B. & Oraby, M. Versatile applications of a spectrofluorimetric approach based on photo-induced electron transfer blocking of Lurasidone. J. Mol. Liq. 391, 123264 (2023).
doi: 10.1016/j.molliq.2023.123264
Gałuszka, A., Migaszewski, Z. M., Konieczka, P. & Namieśnik, J. Analytical Eco-scale for assessing the greenness of analytical procedures. TrAC - Trends Anal. Chem. 37, 61–72 (2012).
doi: 10.1016/j.trac.2012.03.013
Derayea, S. M., Oraby, M., Zaafan, A. S., Hamad, A. A. & Nagy, D. M. A facile on – off fluorescence approach for fluvoxamine determination in pharmaceutical tablets; application to content uniformity testing. RSC Adv. 14, 8283–8292 (2024).
pubmed: 38469194
pmcid: 10926349
doi: 10.1039/D3RA08257A
Płotka-Wasylka, J. A new tool for the evaluation of the analytical procedure: Green Analytical Procedure Index. Talanta. 181, 204–209 (2018).
pubmed: 29426502
doi: 10.1016/j.talanta.2018.01.013
Derayea, S. M., Zaafan, A. S., Nagi, D. A., Oraby, M. & Spectrochimica Acta Part, A. Molecular and Biomolecular Spectroscopy Augmentation of Brexpiprazole fluorescence through photoinduced electron transfer inhibition for the sensitive spectrofluorimetric assay of pharmaceutical dosage forms and spiked human p. Spectrochim Acta Part. Mol. Biomol. Spectrosc. 301, 122948 (2023).
doi: 10.1016/j.saa.2023.122948
Pena-Pereira, F., Wojnowski, W. & Tobiszewski, M. AGREE - Analytical GREEnness Metric Approach and Software. Anal. Chem. 92, 10076–10082 (2020).
pubmed: 32538619
pmcid: 7588019
doi: 10.1021/acs.analchem.0c01887
Manousi, N., Wojnowski, W., Płotka-Wasylka, J. & Samanidou, V. Blue applicability grade index (BAGI) and software: a new tool for the evaluation of method practicality. Green. Chem. 25, 7598–7604 (2023).
doi: 10.1039/D3GC02347H
Derayea, S. M., Elhamdy, H. A., El-Din, B., Oraby, M. & K. M. & Novel spectrofluorometric approach for assessing vilazodone by blocking photoinduced electron transfer: analytical performance, and greenness-blueness evaluation. RSC Adv. 14, 4065–4073 (2024).
pubmed: 38288155
pmcid: 10823494
doi: 10.1039/D3RA08034J