Advances in quality control through the development of a more sustainable and eco-friendly direct spectrophotometric method than pharmacopoeial methods for the determination of bisoprolol fumarate

Authors

DOI:

https://doi.org/10.22456/2527-2616.146133

Keywords:

spectrophotometry, bisoprolol fumarate, eco-friendly, tablets

Abstract

A sustainable eco-friendly direct spectrophotometric method was developed and validated for the estimation of bisoprolol fumarate (BF) in the marketed dosage form. BF in an aqueous medium of 0.10 N NaOH exhibits a maximum absorption at 273 nm that permits its direct estimation by zero-order spectrophotometric method without any interference in a linear range of 1.66–190.0 μg mL-1 (r = 0.9999, n = 5) with detection and quantitation limits were 0.211 and 0.638 μg mL-1, respectively. The suggested method was successfully adopted to evaluate BF in bulk and tablets. The technique showed adequate precision, with a relative standard deviation value lower than 1.78%. Excellent values of accuracy were obtained, with a recovery mean value of 100.37%. The results indicated that the proposed method is highly efficient in determining the amount of BF in the tablets, which helps improve quality control and environmental improvement. Furthermore, the greenness and whiteness profile of the method was evaluated using different evaluation metrics; AES, AGREE, AGREEprep, GAPI, BAGI, and RGB12. The proposed spectrophotometric method was more sustainable, eco-friendly, efficient, productive, and practical than the reported HPLC-UV methods (BP and USP), as confirmed by the absence of consumption of chemical reagents and polluting organic solvents, reduced analysis stages, energy consumption, analysis time and low cost, making it a safer alternative to be considered.

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References

Martindale, The Complete Drug Reference, Sweetman SC (editor), 36th Ed., USA, 2009. ISBN 978 0 85369 840 1.

2. British Pharmacopeia. "Bisoprolol Fumarate Monograph" and "Bisoprolol Fumarate Tablets Specific Monograph". Medicines and Healthcare Products Regulatory Agency, London; 2024.

3. United States Pharmacopeia. USP 43–NF 38. Rockville: The United States Pharmacopoeial Convention; 2020.

4. Mohammed FS, AbdAlkareem SA, AbdAlrhman SM, Osman HM, Abdelwahid MAS, Gaily MM. Development of acid–base titrimetric method for determination of bisoprolol fumarate in raw material and tablet dosage form. Int J Multidisciplin Curr Res. 2016; 4: 972–975. http://ijmcr.com/

5. Ramadan NK, Zaazaa HF. Membrane electrodes for determination of some β-blocker drugs. J AOAC Int. 2007; 90(4): 987-994. https://doi.org/10.1093/jaoac/90.4.987

6. Hassan SSM, Abou-Sekkina MM, El-Ries MA, Wassel AA. Polymeric matrix membrane sensors for sensitive potentiometric determination of some beta-blockers in pharmaceutical preparations. J Pharm Biomed Anal. 2003; 32(1): 175-180. https://doi.org/10.1016/S0731-7085(03)00015-3

7. Frag EY, Mohamed ME, El-Boraey HA, EL-Sanafery SS. Carbon potentiometric sensors modified with beta-cyclodextrin as a carrier for the determination of bisoprolol fumarate. International Journal of Electrochemical Science 2019; 14: 6603–6616. https://doiorg/10.20964/2019.07.40

8. Elgendy K, Elmosallamy MAF, Soltan MK, Amin AS, Elshaprawy DS. Novel potentiometric methods for the estimation of bisoprolol and alverine in pharmaceutical forms and human serum. Rev Anal Chem. 2021; 40: 127–135. https://doi.org/10.1515/revac-2021-0129

9. Goyal RN, Tyagi A, Bachheti N, Bishnoi S. Voltammetric determination of bisoprolol fumarate in pharmaceutical formulations and urine using single-wall carbon nanotubes modified glassy carbon electrode. Electrochim Acta. 2008; 53(6): 2802–2808. https://doi.org/10.1016/j.electacta.2007.10.057

10. Goyal RN, Chatterjee S, Singh SP, Rana ARS, Chasta H. The electrocatalytic activity of bare pyrolytic graphite and single wall carbon nanotube modified glassy carbon sensors is same for the quantification of bisoprolol fumarate. Am J Anal Chem. 2012; 3: 106–112. http://dx.doi.org/10.4236/ajac.2012.32015

11. Wang WX, Gao LJ, Shi TS. HPLC determination of the content of bisoprolol fumarate tablets. Chin J Pharm Anal. 1999; 19(5): 308–310. https://www.ingentaconnect.com/content/jpa/cjpa/1999/00000019/00000005/art00006

12. Induri M, Raju BM, Prasad RY. Validated and stability indicating liquid chromatography method for quantification of bisoprolol fumarate in tablet dosage form. Int J Pharm. 2012; 2(1): 64–70. http://www.pharmascholars.com/

13. Kondratova Y, Logoyda L, Voloshko Y, Abdel-Megied A, Korobko D, Soroka Y. Development and validation of HPLC-DAD method for the determination of bisoprolol in tablet dosage forms. Int J Appl Pharm. 2017; 9(6): 54–59. http://dx.doi.org/10.22159/ijap.2017v9i6.21616

14. Todevska EL, Piponski M, Stefova M. Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD. Macedonian J Chem Chem Eng. 2021; 40(20): 263–276. https://doi.org/10.20450/mjcce.2021.2430

15. Bhavyasri K, Goud JS, Sewthasri R, Sumakanth M. Development and validation of stability indicating Rp-Hplc method for the estimation of bisoprolol fumarate in bulk and pharmaceutical dosage form. Int J Pharm Phytopharmacol Res. 2020; 10(4): 49–70. https://eijppr.com/7q-NQjh

16. Gibril ABM, Rudwan EH. Design of optimized RP-HPLC method for quantitative analysis of bisoprolol fumarate in bulk and pharmaceutical dosage form. Schol Int J Chem Mater Sci. 2023; 6(4): 91–99. http://dx.doi.org/10.36348/sijcms.2023.v06i04.005

17. Aade MM. Development and validation of analytical method for estimation of bisoprolol fumarate in bulk and solid dosage form by RP-HPLC. Int J Pharm Res Appl. 2023; 8(6): 1712–1719. https://doi.org/10.35629/7781-080617121719

18. Panainte (Gudruman) AD, Bibire N, Țântaru G, Apostu M, Vieriu M. Validation of a spectrophotometric assay method for bisoprolol using picric acid. Revista medico-chirurgicala a Societatii de Medici si Naturalisti, Iaşi 2013; 117(2): 520–524. https://www.researchgate.net/publication/259347577

19. Ulu ST, Elif Kel E. Spectrophotometric determination of bisoprolol in pharmaceutical preparations by charge transfer reactions1. Opt Spectrosc. 2012; 112(6): 864–867. http://doi.org/10.1134/s0030400x12060197

20. Ayad MM, Abdellatef HE, Hosny MM, Kabil NA. Aggregation of gold nanoparticles for spectrophotometric determination of bisoprolol hemifumarate, buspirone HCl and doxazosin mesylate. Nano Biomed Eng. 2019; 11(1): 1–10. http://dx.doi.org/10.5101/nbe.v11i1.p1-10

21. Sharma S, Sharma MC. Novel method for spectrophotometric analysis of simultaneous estimation of bisoprolol fumarate tablet formulations using hydrotropy solubilization agents. J Optoelec Biomed Mater. 2010; 2(4): 223–225. http://chalcogen.ro/223_Sharma.pdf

22. El-Shaprawy DS, Elmosallmy MF, Elgendy K. Spectrophotometric determination of bisoprolol fumarate and levobunolol hydrochloride in bulk and pharmaceutical forms. Eurasian J Anal Chem. 2020; 15(1): 20–31. https://www.researchgate.net/publication/339045593

23. Mohammed SA, Adam ME, Shantier SW. Development and validation of UV spectrophotometric method for determination of bisoprolol fumarate in bulk and pharmaceutical dosage forms. Mediterran J Chem. 2017; 6(5): 196–199. http://dx.doi.org/10.13171/mjc65/01710181149-shantier

24. Tripathy SN, Swain S, Jena BR, Sahu A. New validated UV spectrophotometric method for the quantification of bisoprolol fumarate in its pharmaceutical dosage form. Acta Sci Pharm Sci. 2023; 7(2): 4-9. http://dx.doi.org/10.31080/ASPS.2023.07.0927

25. Patil S, Tamboli A, Jokar S, More S. Development and validation of UV spectrophotometric method for bisoprolol fumarate in bulk and tablet dosage form. World J Pharm Res. 2020; 9(7): 1908–1915. https://doi.org/10.20959/wjpr20207-17908

26. Prabhakar M, Vamshi RM, Shirisha RN, Neha B, Venkateswara RP, Akiful HM, Vasudha B, Narender B. Development and validation of UV spectrophotometric method for the determination of bisoprolol in bulk material and in tablets. Int J Biol Pharm Allied Sci. 2023; 12(6): 2822-2834. https://doi.org/10.31032/IJBPAS/2023/12.6.7214

27. El-Didamony AM, Shehata AM. Spectrophotometric determination of β-adrenergic antagonists drugs via ion-pair complex formation using MO and EBT. Optics and Spectroscopy 2014; 117(3): 492–499. https://link.springer.com/article/10.1134/S0030400X14090069

28. Panainte AD, Bibire N, Ţântaru G, Apostu M, Vieriu M, Dorneanu V. Spectrophotometric method for estimation of bisoprolol fumarate in tablets. Revista medico-chirurgicala a Societatii de Medici si Naturalisti, Iaşi 2014; 118(2): 558–563. https://pubmed.ncbi.nlm.nih.gov/25076731/#linkout

29. Ashour S, Al-khalil R, Alfares B. Hydrochlorothiazide used as diuretic with antihypertensive agents in pharmaceutical preparations. estimation by first-order derivative and extractive spectrophotometry. Canad Chem Trans. 2014; 2(2): 190-200. http://canchemtrans.ca/uploads/journals/CCT-2014-0085.pdf

30. Tobiszewski M. Metrics for green analytical chemistry. Anal Meth. 2016; 8: 2993–2999. http://dx.doi.org/10.1039/C6AY00478D

31. Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE—Analytical GREEnness metric approach and software. Anal Chem. 2020; 92: 10076–10082. https://dx.doi.org/10.1021/acs.analchem.0c01887

32. Yenduri S, Koppuravuri NP, Varalakshmi HN. Assessment and comparison of sustainability aspects of UV-spectroscopy methods for simultaneous determination of antihypertensive combination. Green Anal Chem. 2024; 9: 100108, http://dx.doi.org/10.1016/J.GREEAC.2024.100108

33. Wojnowski W, Tobiszewski M, Pena-Pereira F, Psillakis E. AGREEprepe Analytical greenness metric for sample preparation. Trends Anal Chem. 2022; 149: 116553. https://doi.org/10.1016/j.trac.2022.116553

34. Gałuszka A, Migaszewski ZM, Konieczka P, Namieśnik J. Analytical Eco-Scale for assessing the greenness of analytical procedures. Trends Anal Chem. 2012; 37: 61–72. http://dx.doi.org/10.1016/j.trac.2012.03.013

35. Shi M, Zheng X, Zhang N, Guo Y, Liu M, Yin L. Overview of sixteen green analytical chemistry metrics for evaluation of the greenness of analytical methods. Trends Anal Chem. 2023; 166: 117211. https://doi.org/10.1016/j.trac.2023.117211

36. Sajid M, Płotka-Wasylka J. Green analytical chemistry metrics: A review. Talanta 2022; 238: 123046. https://doi.org/10.1016/j.talanta.2021.123046

37. Płotka-Wasylka J. A new tool for the evaluation of the analytical procedure: green analytical procedure index. Talanta 2018; 181: 204–209. https://doi.org/10.1016/j.talanta.2018.01.013

38. Płotka-Wasylka J, Wojnowski W. Complementary green analytical procedure index (ComplexGAPI) and software. Green Chem. 2021; 23: 8657–8665. https://doi.org/10.1039/D1GC02318G

39. 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. 2023; 25: 7598–7604. https://doi.org/10.1039/D3GC02347H

40. Nowak PM, Kościelniak P. What color is your method? Adaptation of the RGB additive color model to analytical method evaluation. Anal Chem. 2019; 91: 10343–10352. http://dx.doi.org/10.1021/acs.analchem.9b01872

41. Nowak PM, Wietecha-Posłuszny R, Pawliszyn J. White analytical chemistry: an approach to reconcile the principles of green analytical chemistry and functionality. Trends Anal Chem. 2021; 138: 116223. http://dx.doi.org/10.1016/J.TRAC.2021.116223

42. Saleh SS, Obaydo RH, El Hamd MA, Rostom Y, Mohamed D, Lotfy HM. Guidelines for accurate application of green and white analytical concepts: merits versus demerits with insights of significant milestones of assessment tools applied for antiviral drugs. Microchem J. 2024; 199: 109917. http://dx.doi.org/10.1016/j.microc.2024.109917

43. ICH, Q2 (R2). Validation of analytical procedures- An Overview of the Revised Guideline, 2024. https://database.ich.org/sites/default/files/ICH_Q2%28R2%29_Guideline_2023_1130.pdf

44. Long GL, Winefordner JD. Limit of detection, A closer look at the IUPAC definition. Anal Chem. 1983; 55: 712A–724A. http://dx.doi.org/10.1021/ac00258a001

45. Miller JN, Miller JC. Statistics and Chemometrics for Analytical Chemistry, Pearson Education Limited, Edinburgh Gate, Harlow, Essex CM20 2JE, England, 6th ed., 2010.

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Published

2025-07-18

How to Cite

Ashour, S. (2025). Advances in quality control through the development of a more sustainable and eco-friendly direct spectrophotometric method than pharmacopoeial methods for the determination of bisoprolol fumarate. Drug Analytical Research, 9(1), 22–31. https://doi.org/10.22456/2527-2616.146133

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ORIGINAL ARTICLES