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Sensitive and validated TLC densitometry method coupled with fluorescence detection for quantitative determination of the newly co-formulated drugs, celecoxib and amlodipine besylate in tablet dosage form

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
New, sensitive, rapid, cost-effective, and validated stability-indicating thin layer chromatographic (TLC) method coupled with fluorescence (FL) detection was developed for the quantitative analysis of celecoxib (CEL) and amlodipine besylate (AMLO) in their laboratory prepared binary mixture using the non-fluorescent TLC silica gel 60 plates. Ethyl acetate: diethylamine: 1-propanol (9:1:0.2, V/V) was used as a developing system. The retention factor (Rf) for each drug was 0.80 ± 0.03 and 0.44 ± 0.01 for CEL and AMLO, respectively. The plates were excited at 264 nm for the simultaneous FL measurement of CEL and AMLO, the calibration curves were linear over a concentration ranges of 30.0–300.0 ng/band and 15.0–150.0 ng/band with mean percentage recoveries of 99.80 ± 0.85 and 99.80 ± 0.77 For CEL and AMLO, respectively. The developed method was applied for the stability studies of the cited drugs in their laboratory prepared binary mixture and the forced degradation products were determined when present in presence of the pure drugs so the method can be considered as a stability-indicating one and it was validated as per ICH guidelines and proved to be accurate and precise.
Rocznik
Strony
150--161
Opis fizyczny
Bibliogr. 41 poz., rys., tab.
Twórcy
autor
  • Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, EinHelwan, 11795, Cairo, Egypt
autor
  • Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, EinHelwan, 11795, Cairo, Egypt
autor
  • Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, EinHelwan, 11795, Cairo, Egypt
autor
  • Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, EinHelwan, 11795, Cairo, Egypt
Bibliografia
  • 1. Angeli, F.; Trapasso, M.; Signorotti, S; Verdecchia, P; Reboldi, G. Amlodipine and celecoxib for treatment of hypertension and osteoarthritis pain. Expert Rev. Clin. Pharmacol. 2018, 11, 1073–84. https://doi.org/10.1080/17512433.2018.1540299.
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  • 3. Smith, S. M.; Cooper-DeHoff, R. M. Fixed-dose combination amlodipine/celecoxib (consensi) for hypertension and osteoarthritis. Am. J. Med. 2019, 132, 172–4. https://doi.org/10.1016/j.amjmed.2018.08.027.
  • 4. Kim, S; Chen, J.; Cheng, T; Gindulyte, A; He, J; He, S; Li, Q; Shoemaker, B. A.; Thiessen, P. A.; Yu, B; Zaslavsky, L.; Zhang, J.; Bolton, E. E. PubChem 2019 update: improved access to chemical data. Nucleic Acids Res. 2019, 47, D1102–9. https://doi.org/10.1093/nar/gky1033.
  • 5. Antoniou, K; Malamas, M; Drosos, A. A. Clinical pharmacology of celecoxib, a COX-2 selective inhibitor. Expert Opin. Pharmacother. 2007, 8, 1719–32. https://doi.org/10.1517/14656566.8.11.1719.
  • 6. Maatouk, I. ; Wild, B. ; Herzog, W. ; Wesche, D. ; Schellberg, D. ; Schöttker, B. ; Müller, H. ; Rothenbacher, D. ; Stegmaier, C. ; Brenner, H. Longitudinal predictors of health-related quality of life in middle-aged and older adults with hypertension. J. Hypertens. 2012, 30, 1364–1372. https://doi.org/10.1097/HJH.0b013e328353d81b.
  • 7. Jarari, N.; Rao, N.; Peela, J. R.; Ellafi, K. A.; Shakila, S.; Said, A. R.; Nelapalli, N. K.; Min, Y.; Tun, K. D.; Jamallulail, S. I.; Rawal, A. K.; Ramanujam, R.; Yedla, R. N.; Kandregula, D. K.; Argi, A.; Peela, L. T. A review on prescribing patterns of antihypertensive drugs. Clin. Hypertens. 2015, 22, 1–8. https://doi.org/10.1186/s40885-016-0042-0.
  • 8. Patel, N. S.; Nandurbarkar, V. P.; Patel, A. J.; Patel, S. G. Simultaneous spectrophotometric determination of Celecoxib and Diacerein in bulk and capsule by absorption correction method and chemometric methods. Spectrochim. Acta - Part A. 2014, 125, 46–52. https://doi.org/10.1016/J.SAA.2014.01.036.
  • 9. Darbandi, A.; Sohrabi, M. R.; Bahmaei, M. Development of a chemometric-assisted spectrophotometric method for quantitative simultaneous determination of Amlodipine and Valsartan in commercial tablet. Optik (Stuttg). 2020, 218, 165110. https://doi.org/10.1016/j.ijleo.2020.165110.
  • 10. Attimarad, M.; Chohan, M. S.; Elgorashe, R. E. E. Smart analysis of a ternary mixture of amlodipine, hydrochlorothiazide and telmisartan by manipulation of UV spectra: development, validation and application to formulations. J. Mol. Struct. 2020, 1212, 128095. https://doi.org/10.1016/j.molstruc.2020.128095.
  • 11. Lotfy, H. M.; Erk, N.; Rostom, Y. Developing spectral numerical factor technique for the determination of amlodipine besylate and the latest generation of statins in their new pharmaceutical combination. Spectrochim. Acta - Part A. 2019, 218, 320–30. https://doi.org/10.1016/j.saa.2019.04.017.
  • 12. Damiani, P.; Bearzotti, M.; Cabezón, M. A. A validated spectrofluorometric method for the determination of celecoxib in capsules. Anal. Bioanal. Chem. 2003, 376, 1141–6. https://doi.org/10.1007/s00216-003-1975-1.
  • 13. Mohamed, A. M. I.; Omar, M. A.; Hammad, M. A.; Mohamed, A. A. Development and validation of highly sensitive stability indicating spectrofluorimetric method for determination of amlodipine in pharmaceutical preparations and human plasma. J. Fluoresc. 2016, 26, 2141–9. https://doi.org/10.1007/s10895-016-1910-4.
  • 14. Shaalan, R. A.; Belal, T. S. Simultaneous spectrofluorimetric determination of amlodipine besylate and valsartan in their combined tablets. Drug Test. Anal. 2010, 2, 489–93. https://doi.org/10.1002/dta.160.
  • 15. Abdel-Wadood, H. M.; Mohamed, N. A.; Mahmoud, A. M. Validated spectrofluorometric methods for determination of amlodipine besylate in tablets. Spectrochim. Acta - Part A. 2008, 70, 564–70. https://doi.org/10.1016/j.saa.2007.07.055.
  • 16. Lakshmi, K. S.; Lakshmi, S. Simultaneous analysis of losartan potassium, amlodipine besylate, and hydrochlorothiazide in bulk and in tablets by high-performance thin layer chromatography with UV-absorption densitometry. J. Anal. Methods. Chem. 2012, 2012. https://doi.org/10.1155/2012/108281.
  • 17. Vekariya, N. R.; Patel, G. F.; Bhatt, M. H .S.; Patel, M. M. B.; Dholakiya, R. B.; Dhanvantary, S.; College, P.; Surat, D. Application of TLC-densitometry method for simultaneous estimation of telmisartan and amlodipine besylate in pharmaceutical dosage form. Int. J. Pharmtech Res. 2009, 1, 1644–9.
  • 18. Patel, T. R.; Patel, T. B.; Suhagia, B. N.; Shah, S. A. HPTLC method for simultaneous estimation of aliskiren, amlodipine and hydrochlorothiazide in synthetic mixture using quality by design approach. J. Liq. Chromatogr. Relat. Technol. 2015, 38, 1546–54. https://doi.org/10.1080/10826076.2015.1076461.
  • 19. Sharma, M.; Kothari, C.; Sherikar, O.; Mehta, P. Concurrent estimation of amlodipine besylate , hydrochlorothiazide and valsartan by RP-HPLC , HPTLC and UV-spectrophotometry. J. Chromatogr. Sci. 2014, 25, 27–35. https://doi.org/10.1093/chromsci/bms200 Advance.
  • 20. Varghese, S. J.; Ravi, T. K.; Nadu, T. Quantitative simultaneous determination of hydrochlorothiazide in “ EXFORGE HCT ” tablets using high-performance liquid chromatography and high-performance thin - layer liquid chromatography. J. Liq. Chromatogr. Relat. Technol. 2011, 34, 981–94. https://doi.org/10.1080/10826076.2011.565539.
  • 21. Gupta, K. R.; Wankhede, S. B.; Tajne, M. R.; Wadodkar, S. G. Simultaneous determination of amlodipine and ramipril by high performance thin layer chromatography. Asian J. Chem. 2007, 19, 4177–82.
  • 22. Sane, R. T; Pandit, S.; Khedkar, S. High-performance thin-layer chromatographic determination of celecoxib in its dosage form. J. Planar Chromatogr. Mod. TLC 2004, 17, 61–4. https://doi.org/10.1556/JPC.17.2004.1.14.
  • 23. Darwish, H. W.; Hassan, S. A.; Salem, M. Y.; El-Zeany, B. A. Rapid and sensitive TLC and HPLC with on-line wavelength switching methods for simultaneous quantitation of amlodipine, valsartan and hydrochlorothiazide in pharmaceutical dosage forms. Int. J. Pharma Bio Sci. 2013, 4, 345–56.
  • 24. Soliman, M. M.; Darwish, M. K.; Abdel-razeq, S. A. Determination of amlodipine besilate and azilsartan medoxomil by UHPLC , HPTLC and spectrophotometric techniques. Int. Res. J. Pure Appl. Chem. 2019, 19, 1–13. https://doi.org/10.9734/IRJPAC/2019/v19i330109.
  • 25. Thomas, A. B.; Jagdale, S. N.; Nanda, R. K.; Kothapalli, L. P.; Deshpande, A. D. Stability indicating HPTLC method for the simultaneous determination of amlodipine besylate and telmisartan from tablet dosage form. J. Pharm. Res. 2011, 10, 66–72.
  • 26. Wankhede, S. B.; Raka, K. C.; Wadkar, S. B.; Chitlange, S. S. Development and validation of stability-indicating HPTLC method for analysis of amlodipine besilate, losartan potassium and hydrochlorothiazide in pharmaceutical dosage form. J. Pharm. Res. 2010, 9, 60–2.
  • 27. Dhaneshwar, S. R.; Patre, N. G.; Mahadik, M. V. Validated TLC method for simultaneous quantitation of amlodipine besylate and valsartan in bulk drug and formulation. Chromatographia. 2009, 69, 157–61. https://doi.org/10.1365/s10337-008-0858-1.
  • 28. Shah, D. A.; Patel, D. V.; Mehta, F. A.; Chhalotiya, U. K.; Bhatt, K. K. High-performance thin-layer chromatography method for estimating the stability of a combination of irbesartan and amlodipine besylate. J. Taibah Univ. Sci. 2015, 9, 177–86. https://doi.org/10.1016/j.jtusci.2014.07.007.
  • 29. Tamboli, A. M.; Khan, N. I.; Bathe, R. S.; Ansari, A. M. HPTLC method for simultaneous determination of amlodipine besylate and enalapril maleate in pharmaceutical formulation. Int. J. Biomed. Adv. Res. 2014, 5, 238–41. https://doi.org/10.7439/ijbar.
  • 30. Dhandapani, B.; Anjaneyulu, N.; Venkateshwarlu, Y.; Rasheed, S. H. HPTLC method development and validation for the simultaneous estimation of amlodipine besylate and Nebivolol hydrochloride in tablet dosage form. J. Pharm. Res. 2010, 3, 332–4.
  • 31. Navas, N.; Ure~na, R.; Capitan-Vallvey, L. F. Determination of celecoxib, rofecoxib, sodium diclofenac and niflumic acid in human serum samples by HPLC with DAD detection. Chromatographia. 2008, 67, 55–61. https://doi.org/10.1365/s10337-007-0445-x.
  • 32. Mabrouk, M. M.; Hammad, S. F.; El-Malla, S. F.; Elshenawy, E. A. Green micellar HPLC-fluorescence method for simultaneous determination of metoprolol and amlodipine in their combined dosage form: application onmetoprolol in spiked human plasma. Microchem. J. 2019, 147, 635–42. https://doi.org/10.1016/j.microc.2019.03.084.
  • 33. Elkady, E. F.; Mandour, A. A.; Algethami, F. K.; Aboelwafa, A. A.; Farouk, F. Sequential liquid-liquid extraction coupled to LC-MS/ MS for simultaneous determination of amlodipine, olmesartan and hydrochlorothiazide in plasma samples: application to pharmacokinetic studies. Microchem. J. 2020, 155, 104757. https://doi.org/10.1016/j.microc.2020.104757.
  • 34. Arkan, E.; Karimi, Z.; Shamsipur, M.; Saber, R. Electrochemical determination of celecoxib on a graphene based carbon ionic liquid electrode modified with gold nanoparticles and its application to pharmaceutical analysis. Anal. Sci. 2013, 29, 855–60. https://doi.org/10.2116/analsci.29.855.
  • 35. Mansano, G. R.; Paula, A.; Eisele, P.; Henrique, L.; Antonia, D.; Afonso, S.; Sartori, E. R. Electroanalytical application of a borondoped diamond electrode : improving the simultaneous voltammetric determination of amlodipine and valsartan in urine and combined dosage forms. J. Electroanal. Chem. 2015, 738, 188–94. https://doi.org/10.1016/j.jelechem.2014.11.034.
  • 36. Attimarad, M.; Narayanswamy, V. K.; Aldhubaib, B. E.; SreeHarsha, N.; Nair, A. B. Development of UV spectrophotometry methods for concurrent quantification of amlodipine and celecoxib by manipulation of ratio spectra in pure and pharmaceutical formulation. PLoS One. 2019, 14. https://doi.org/10.1371/journal.pone.0222526.
  • 37. Attala, K.; Eissa, M. S.; Hasan, M. A.; El-henawee, M. M.; El-hay, S. S. A. An enhanced fi rst derivative synchronous spectrofluorimetric method for determination of the newly co-formulated drugs, amlodipine and celecoxib in pharmaceutical preparation and human plasma. Spectrochim. Acta Part A 2020, 240, 118533. https://doi.org/10.1016/j.saa.2020.118533.
  • 38. Attimarad, M.; Venugopala, K. N.; SreeHarsha, N.; Aldhubiab, B. E.; Nair, A. B. Validation of rapid RP-HPLC method for concurrent quantification of amlodipine and celecoxib in pure and formulation using an experimental design. Microchem. J. 2020, 152, 104365. https://doi.org/10.1016/j.microc.2019.104365.
  • 39. Abdel Hamid, M. A.; Mabrouk, M. M.; Michael, M. A. A fast and green reversed-phase HPLC method with fluorescence detection for simultaneous determination of amlodipine and celecoxib in their newly approved fixed-dose combination tablets. J. Sep. Sci. 2020, 1–9. https://doi.org/10.1002/jssc.202000345.
  • 40. Variyar, P. S.; Chatterjee, S.; Sharma, A. Fundamentals and theory of HPTLC-based separation. In High-Performance Thin-Layer Chromatography (HPTLC), Springer Heidelberg: Dordrecht London New York, 2011, vol. 27, p. 39. https://doi.org/10.1007/978-3-642-14025-9.
  • 41. ICH, Guidelines, Validation of Analytical Procedures: Text and Methodology Q2 (R1), International Conference on Harmonization, Geneva, Switzerland, 2005, pp. 5–11.
Uwagi
Opracowanie rekordu ze środków MEiN, umowa nr SONP/SP/546092/2022 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2022-2023).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-766a83df-e3c9-4ee3-b942-dc538d26fb45
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