Risk assessment based on spectrophotometric signals used in eco-friendly analytical scenarios for estimation of carvedilol and hydrochlorothiazide in pharmaceutical formulation.
Absorbance resolution (AR)
Carvedilol
Greenness profile
Hydrochlorothiazide
Induced absorbance resolution (IAR)
Spectrum subtraction (SS)
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
23 Aug 2024
23 Aug 2024
Historique:
received:
24
04
2024
accepted:
08
08
2024
medline:
24
8
2024
pubmed:
24
8
2024
entrez:
23
8
2024
Statut:
epublish
Résumé
Special attention is given to the pharmacological treatment of combined medication of Carvedilol and hydrochlorothiazide which is the most effective and the most beneficial therapy for hypertensive patients with diabetes and various metabolic comorbidities. This work represents spectrophotometric platform scenarios based on factorized spectrum (FS) using interpoint data difference resolution scenarios (IDDRS) coupled with spectrum subtraction method (SS) for the concurrent quantification of carvedilol (CAR) and hydrochlorothiazide (HCT) when present together in a combination without the need for any initial physical separation steps. This IDD resolution scenario based on manipulating the zero-order spectra (D
Identifiants
pubmed: 39179633
doi: 10.1038/s41598-024-69746-0
pii: 10.1038/s41598-024-69746-0
doi:
Substances chimiques
Carvedilol
0K47UL67F2
Hydrochlorothiazide
0J48LPH2TH
Antihypertensive Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
19657Informations de copyright
© 2024. The Author(s).
Références
Guerrero-García, C. & Rubio-Guerra, A. F. Combination therapy in the treatment of hypertension. Drugs Context 7, 212531 (2018).
pubmed: 29899755
pmcid: 5992964
doi: 10.7573/dic.212531
Petrie, J. R., Guzik, T. J. & Touyz, R. M. Diabetes, hypertension, and cardiovascular disease: Clinical insights and vascular mechanisms. Can. J. Cardiol. 34(5), 575–584 (2018).
pubmed: 29459239
doi: 10.1016/j.cjca.2017.12.005
Abdelwahab, N. S. Spectrophotometric methods for simultaneous determination of carvedilol and hydrochlorothiazide in combined dosage form. Arab. J. Chem. 9, S355–S360 (2016).
doi: 10.1016/j.arabjc.2011.05.002
Stafylas, P. C. & Sarafidis, P. A. Carvedilol in hypertension treatment. Vasc. Health Risk Manag. 4(1), 23–30 (2008).
pubmed: 18629377
pmcid: 2464772
doi: 10.2147/vhrm.2008.04.01.23
Giugliano, D. et al. Metabolic and cardiovascular effects of carvedilol and atenolol in non-insulin-dependent diabetes mellitus and hypertension: a randomized, controlled trial. Ann. Int. Med. 126(12), 955–959 (1997).
pubmed: 9182472
doi: 10.7326/0003-4819-126-12-199706150-00004
Uzunlulu, M., Oguz, A. & Yorulmaz, E. The effect of carvedilol on metabolic parameters in patients with metabolic syndrome. Int. Heart J. 47(3), 421–430 (2006).
pubmed: 16823248
doi: 10.1536/ihj.47.421
Bakris, G. L. et al. Metabolic effects of carvedilol vs metoprolol in patients with type 2 diabetes mellitus and hypertension: A randomized controlled trial. Jama 292(18), 2227–2236 (2004).
pubmed: 15536109
doi: 10.1001/jama.292.18.2227
Dulin, B. & Abraham, W. T. Pharmacology of carvedilol. Am. J. Cardiol. 93(9), 3–6 (2004).
doi: 10.1016/j.amjcard.2004.01.003
Pharmacopoeia, B. volume I in: British Pharmacopoeia Commission, London, TSO, UK., 2022; 0499 and 0559; for CAR and HCT, respectively.
Ieggli, C. V. S., Cardoso, S. G. & Belle, L. P. Validation of UV spectrophotometric and nonaqueous titration methods for the determination of carvedilol in pharmaceutical formulations. J. AOAC Int. 88(5), 1299–1303 (2005).
pubmed: 16385978
doi: 10.1093/jaoac/88.5.1299
Chanduluru, H. & Sugumaran, A. Three spectrophotometric approaches for measuring ratio spectra of Ivabradine and Carvedilol in a binary mixture using green analytical principles. Curr. Chem. Lett. 11(3), 321–330 (2022).
doi: 10.5267/j.ccl.2022.3.002
Islam, M. S., Sultan, M. Z., Islam, M. S., Simol, H. A. & Salam, M. A. Development and validation of a new method for simultaneous estimation of ramipril and carvedilol by HPLC. Bangladesh Pharm. J. 26(1), 15–19 (2023).
doi: 10.3329/bpj.v26i1.64213
Duarte, J. D. & Cooper-DeHoff, R. M. Mechanisms for blood pressure lowering and metabolic effects of thiazide and thiazide-like diuretics. Expert Rev. Cardiovasc. Ther. 8(6), 793–802 (2010).
pubmed: 20528637
pmcid: 2904515
doi: 10.1586/erc.10.27
Kumar, V., Singh, B. K. & Shukla, I. C. Determination of some diuretic drugs in pure form and their pharmaceutical formulations with ammonium hexanitratocerate (IV). Indian J. Pharm. Educ. Res. 47(3), 64–69 (2013).
doi: 10.5530/ijper.47.3.10
Lotfy, H. M., Hegazy, M. A., Mowaka, S. & Mohamed, E. H. Novel spectrophotometric methods for simultaneous determination of amlodipine, valsartan and hydrochlorothiazide in their ternary mixture. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 140, 495–508 (2015).
doi: 10.1016/j.saa.2014.12.096
Lahsini, R. & Monser, L. Development of a new UPLC method for simultaneous determination of valsartan, amlodipine besylate, and hydrochlorothiazide pharmaceutical products. Acta Chromatogr. 27(3), 449–460 (2015).
doi: 10.1556/AChrom.27.2015.3.4
Benjamin, I. J. et al. Fixed-dose combination antihypertensive medications. The Lancet 394(10199), 637–638 (2019).
doi: 10.1016/S0140-6736(19)31629-0
Ferrua, S. et al. Does carvedilol impair insulin sensitivity in heart failure patients without diabetes?. J. Card. Fail. 11(8), 590–594 (2005).
pubmed: 16230261
doi: 10.1016/j.cardfail.2005.06.431
Kovačić, D., Marinšek, M., Gobec, L., Lainščak, M. & Podbregar, M. Effect of selective and non-selective β-blockers on body weight, insulin resistance and leptin concentration in chronic heart failure. Clin. Res. Cardiol. 97, 24–31 (2008).
pubmed: 17694376
doi: 10.1007/s00392-007-0571-3
Torp-Pedersen, C. et al. Effects of metoprolol and carvedilol on pre-existing and new onset diabetes in patients with chronic heart failure: data from the carvedilol or metoprolol European trial (COMET). Heart 93(8), 968–973 (2007).
pubmed: 17237130
pmcid: 1994413
doi: 10.1136/hrt.2006.092379
Belal, T. S., Shaalan, R. A., Fawzy, A. Y. & Sohila, M. E. Application of a new simple spectrophotometric method for determination of the binary mixtures of hydrochlorothiazide with either carvedilol or losartan potassium in tablets dosage forms. Sch. Res. Lib. Der Pharma Chem. 6(4), 120–129 (2014).
Mali, A. D. Simultaneous determination of carvedilol and hydrochlorothiazide in pharmaceutical dosage form by second Order derivative UV spectrophotometry. Asian J. Pharm. Anal. 5(3), 133–138 (2015).
doi: 10.5958/2231-5675.2015.00021.6
Mali, A., Kekan, V., Dongare, R., Gholve, S. & Bathe, R. Simultaneous UV Spectrophotometric methods for estimation of carvedilol and hydrochlorothiazide in bulk and tablet dosage form. Asian J. Pharm. Res. 6(1), 15–20 (2016).
doi: 10.5958/2231-5713.2016.00002.7
Calvo, N. L., Maggio, R. M. & Kaufman, T. S. An eco-friendly strategy, using on-line monitoring and dilution coupled to a second-order chemometric method, for the construction of dissolution curves of combined pharmaceutical associations. J. Pharm. Biomed. Anal. 89, 213–220 (2014).
pubmed: 24291800
doi: 10.1016/j.jpba.2013.10.043
Haggag, R. S., Shaalan, R. A. & Belal, T. S. Validated HPLC determination of the two fixed dose combinations (chlordiazepoxide hydrochloride and mebeverine hydrochloride; carvedilol and hydrochlorothiazide) in their tablets. J. AOAC Int. 93(4), 1192–1200 (2010).
pubmed: 20922951
doi: 10.1093/jaoac/93.4.1192
Belal, T. S., Shaalan, R. A., El Yazbi, F. A. & Elonsy, S. M. Validated stability-indicating HPLC–DAD determination of the antihypertensive binary mixture of carvedilol and hydrochlorothiazide in tablet dosage forms. Chromatographia 76(23), 1707–1720 (2013).
doi: 10.1007/s10337-013-2537-0
Al-Adl, S. M., Abdel-Aziz, L. M. & Mohamed, M. A. HPLC determination of carvedilol, candesartan cilexetil and hydrochlorothiazide in their bulk and tablet dosage forms. Anal. Chem. Lett. 7(2), 188–200 (2017).
doi: 10.1080/22297928.2017.1326840
Bahgat, E. A., Saleh, H., Reda, A. & Fawzy, M. G. Development and validation of eco-friendly micellar organic solvent-free HPLC method for the simultaneous determination of some antihypertensive combinations. Microchem. J. 181, 107740 (2022).
doi: 10.1016/j.microc.2022.107740
Deventer, K., Van Eenoo, P. & Delbeke, F. T. Simultaneous determination of beta-blocking agents and diuretics in doping analysis by liquid chromatography/mass spectrometry with scan-to-scan polarity switching. Rapid Commun. Mass Spectrom.: Int. J. Devot. Rapid Dissem. Up Min. Res. Mass Spectrom. 19(2), 90–98 (2005).
doi: 10.1002/rcm.1744
Shaalan, R. A., Belal, T. S., El Yazbi, F. A. & Elonsy, S. M. Validated HPTLC methods for determination of some selected antihypertensive mixtures in their combined dosage forms. Bull. Fac. Pharm. Cairo Univ. 52(2), 225–237 (2014).
Alzoman, N. Z., Sultan, M. A., Maher, H. M., AlShehri, M. M. & Olah, I. V. Validated stability-indicating capillary electrophoresis method for the separation and determination of a fixed-dose combination of carvedilol and hydrochlorothiazide in tablets. J. AOAC Int. 96(5), 951–959 (2013).
pubmed: 24282931
doi: 10.5740/jaoacint.11-245
Saleh, S. S., Lotfy, H. M., Elgizawy, S. M. & Hassan, N. Y. A comparative study of spectrophotometric methods versus chemometric methods, an application on a pharmaceutical binary mixture of ofloxacin and dexamethasone. Int. Res. J. Pure Appl. Chem. 3, 90–110 (2013).
doi: 10.9734/IRJPAC/2013/3052
Lotfy, H. M., Tawakkol, S. M., Fahmy, N. M. & Shehata, M. A. A comparative study of novel spectrophotometric resolution techniques applied for pharmaceutical mixtures with partially or severely overlapped spectra. Spectrochim. Acta Part A 136, 937–952 (2014).
doi: 10.1016/j.saa.2014.09.117
Saleh, S. S., Lotfy, H. M., Hassan, N. Y. & Salem, H. A comparative study of progressive versus successive spectrophotometric resolution techniques applied for pharmaceutical ternary mixtures. Spectrochim. Acta Part A 132, 239–248 (2014).
doi: 10.1016/j.saa.2014.05.004
Lotfy, H. M., Hegazy, M. A., Rezk, M. R. & Omran, Y. R. Novel spectrophotometric methods for simultaneous determination of timolol and dorzolamide in their binary mixture. Spectrochim. Acta Part A 126, 197–207 (2014).
doi: 10.1016/j.saa.2014.02.005
Lotfy, H. M., Saleh, S. S., Hassan, N. Y. & Salem, H. A comparative study of novel spectrophotometric methods based on isosbestic points; application on a pharmaceutical ternary mixture. Spectrochim. Acta Part A 126, 112–121 (2014).
doi: 10.1016/j.saa.2014.01.130
Lotfy, H. M., Hegazy, M. A., Rezk, M. R. & Omran, Y. R. Comparative study of novel versus conventional two-wavelength spectrophotometric methods for analysis of spectrally overlapping binary mixture. Spectrochim. Acta Part A 148, 328–337 (2015).
doi: 10.1016/j.saa.2015.04.004
Lotfy, H. M., Mohamed, D. & Mowaka, S. A comparative study of smart spectrophotometric methods for simultaneous determination of sitagliptin phosphate and metformin hydrochloride in their binary mixture. Spectrochim. Acta Part A 149, 441–451 (2015).
doi: 10.1016/j.saa.2015.04.076
Lamie, N. T. & Yehia, A. M. Development of normalized spectra manipulating spectrophotometric methods for simultaneous determination of Dimenhydrinate and Cinnarizine binary mixture. Spectrochim. Acta Part A 150, 142–150 (2015).
doi: 10.1016/j.saa.2015.05.048
Lotfy, H. M. & Saleh, S. S. Recent development in ultraviolet spectrophotometry through the last decade (2006–2016). Int. J. Pharm. Pharm. Sci. 8(10), 40–56 (2016).
doi: 10.22159/ijpps.2016v8i10.13537
Lotfy, H. M., Ahmed, D. A., Rahman, M. K. A. & Weshahy, S. A. F. Study of efficiency and spectral resolution for mathematical filtration technique using novel unlimited derivative ratio and classical univariate spectrophotometric methods for the multicomponent determination-stability analysis. Heliyon 5(5), e01669 (2019).
pubmed: 31193052
pmcid: 6514739
doi: 10.1016/j.heliyon.2019.e01669
Obaydo, R. H., Al Zakri, D. J., Sakur, A. A. & Lotfy, H. M. Ultraviolet spectrophotometric methods for the determination of the minor component presented in fixed-dose pharmaceutical combinations through the last 2 decades (2000–2020). Fut. J. Pharm. Sci. 7, 1–9 (2021).
Lotfy, H., Saleh, S., Rostom, Y., Obaydo, R. & Ahmed, D. Advanced approaches in green univariate spectrophotometric methods. Sustain. Approach. Pharm. Sci. https://doi.org/10.1002/9781119889878.ch8 (2023).
doi: 10.1002/9781119889878.ch8
Lotfy, H. M., El-Hanboushy, S., Fayez, Y. M., Abdelkawy, M. & Marzouk, H. M. Computational intelligence spectrophotometric scenarios for screening and quantification of single-dose triple therapy banned by the world anti-doping agency in some sports. Microchem. J. 196, 109581 (2023).
doi: 10.1016/j.microc.2023.109581
Lotfy, H. M. & Omran, Y. R. Novel absorptivity centering method utilizing normalized and factorized spectra for analysis of mixtures with overlapping spectra in different matrices using built-in spectrophotometer software. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 200, 167–178 (2018).
doi: 10.1016/j.saa.2018.04.004
Lotfy, H. M., Elshahed, M. S. & Mohamed, D. Novel univariate spectrophotometric determination of the recently released solid dosage form comprising dapagliflozin and saxagliptin via factorized response spectra: assessment of the average content and dosage unit uniformity of tablets. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 222, 117120 (2019).
doi: 10.1016/j.saa.2019.05.025
Lotfy, H. M., Mohamed, D. & Elshahed, M. S. The concept of Relative Absorptivity Distribution for enhancing disregioning power of spectrophotometric technique to resolve co-formulated tablets: A tool for purity index and uniformity assessment. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 239, 118551 (2020).
doi: 10.1016/j.saa.2020.118551
Ahmed, D. A. & Lotfy, H. M. Evaluation of in silico and in lab sample enrichment techniques for the assessment of challengeable quaternary combination in critical ratio. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 260, 119943 (2021).
doi: 10.1016/j.saa.2021.119943
Ahmed, D. A. & Lotfy, H. M. Sticking-pulling strategy for assessment of combined medicine for management of tough symptoms in COVID-19 Pandemic using different windows of spectrophotometric platform-counterfeit products’ detection. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 277, 121256 (2022).
doi: 10.1016/j.saa.2022.121256
Rostom, Y., Wadie, M., Rezk, M. R., Marzouk, H. M. & Abdel-Moety, E. M. Fingerprinting and iso-absorptive resolution techniques for the spectrally overlapping Dutasteride and Silodosin mixture: Content uniformity testing along with greenness profile assessment. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 273, 121063 (2022).
doi: 10.1016/j.saa.2022.121063
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
Hussein, O. G., Rostom, Y., Abdelkawy, M., Rezk, M. R. & Ahmed, D. A. Spectrophotometric platform windows’ exploitation for the green determination of Alcaftadine in presence of its oxidative degradation product. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 297, 122737 (2023).
doi: 10.1016/j.saa.2023.122737
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
Hussein, O. G., Rostom, Y., Abdelkawy, M., Rezk, M. R. & Ahmed, D. A. Green TLC-densitometric method for simultaneous determination of Antazoline and Tetryzoline: Application to pharmaceutical formulation and rabbit aqueous humor. J. Chromatograph. Sci. https://doi.org/10.1093/chromsci/bmad042 (2023).
doi: 10.1093/chromsci/bmad042
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
Keith, L. H., Gron, L. U. & Young, J. L. Green analytical methodologies. Chem. Rev. 107, 2695–2708 (2007).
pubmed: 17521200
doi: 10.1021/cr068359e
- International Conference on Harmonization (ICH), Q2B: Validation of Analytical Procedures: Methodology, 62, US FDA, Federal Register (1997).
Lotfy, H. M., Saleh, S. S. & El-Maraghy, C. M. Advanced approaches for the treatment and amplification of weak spectral signals produced by critical concentrations in white multicomponent systems. Spectrochim. Acta Part A: Mol. Biomol. Spectrosc. 224, 117339 (2020).
doi: 10.1016/j.saa.2019.117339
El-Hanboushy, S., Marzouk, H. M., Fayez, Y. M., Abdelkawy, M. & Lotfy, H. M. Sustainable spectrophotometric determination of antihypertensive medicines reducing COVID-19 risk via paired wavelength data processing technique-assessment of purity, greenness and whiteness. Sustain. Chem. Pharm. 29, 100806 (2022).
pubmed: 35992213
pmcid: 9376343
doi: 10.1016/j.scp.2022.100806
Morgan, E. M., Boltia, S. A., Fayez, Y. M., Abdelkawy, M. & Lotfy, H. M. Coupling of physical extraction and mathematical filtration in spectrophotometric analysis of natural therapy essential for prophylaxis and treatment of COVID-19 infection-comparative study along with greenness evaluation. Heliyon 9(6), e16284 (2023).
pubmed: 37235204
pmcid: 10193772
doi: 10.1016/j.heliyon.2023.e16284
Ahmed, D. A., Abdel-Aziz, O., Abdel-Ghany, M. & Weshahy, S. A. Stability indicating determination of Albendazole in bulk drug and pharmaceutical dosage form by chromatographic and spectrophotometric methods. Fut. J. Pharm. Sci. 4(2), 161–165 (2018).
Abd El-Rahman, M. K., Ahmed, D. A., Weshahy, S. A. & Lotfy, H. M. Synchronous UPLC resolution of aceclofenac and diacerin in their powdered forms and matrix formulation: Stability study. J. Chromatograph. Sci. 58(7), 622–628 (2020).
doi: 10.1093/chromsci/bmaa025
Shabir, G. A. Step-by-step analytical methods validation and protocol in the quality system compliance industry. J. Valid. Technol. 10, 314–325 (2005).
Nagaraju, R. & Kanakapura, B. Determination of olanzapine by spectrophotometry using permanganate. Braz. J. Pharm. Sci. 45(3), 532–550 (2009).
Ravisankar, P. et al. Validation characteristics and statistics in analytical method development. High Technol. Lett. 27(7), 76–88 (2021).
Lotfy, H. M., Obaydo, R. H. & Nessim, C. K. Spider chart and whiteness assessment of synergistic spectrophotometric strategy for quantification of triple combination recommended in seasonal influenza-detection of spurious drug. Sustain. Chem. Pharm. 32, 100980 (2023).
doi: 10.1016/j.scp.2023.100980
Michael, A. M., Lotfy, H. M. & Nessim, C. K. Greenness profile and whiteness assessment of the stability-indicating HPLC method for the assay of Levetiracetam. Microchem. J. 190, 108669 (2023).
doi: 10.1016/j.microc.2023.108669
Arunagiri, T. et al. Green analytical chemistry-based spectrophotometric techniques for ternary component analysis of pain relievers. Fut. J. Pharm. Sci. 10(1), 1–13 (2024).
Marzouk, H. M., Ayish, N. S., El-Zeany, B. A. & Fayed, A. S. Green Spectrophotometric resolution platforms of spectrally overlapping signals of antihypertensive ternary pharmaceutical formulation: Application to content uniformity testing. J. Anal. Chem. 78, 1244–1254 (2023).
doi: 10.1134/S1061934823090083