European Journal of Chemistry 2019, 10(1), 52-56. doi:10.5155/eurjchem.10.1.52-56.1815

Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC


Marco Mounir Zaki (1,*) orcid , Nada Sayed Abdelwahab (2) orcid , Adel Ahmed Ali (3) orcid , Souty Mounie Zaki Sharkawi (4) orcid

(1) Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
(2) Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
(3) Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
(4) Pharmacology and Toxicology, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
(*) Corresponding Author

Received: 20 Nov 2018, Accepted: 18 Dec 2018, Published: 31 Mar 2019

Abstract


A simple, specific, and precise RP-HPLC method was developed and validated for simultaneous determination of Bisoprolol fumarate (BIS) and Rosuvastatin calcium (ROS) in new formulated tablets. The developed RP-HPLC method depended on chromatographic separation using C18 column (150×4.6 mm, 0.5 μm) with mobile phase consisted of acetonitrile and 0.05 aqueous solution of orthophosphoric acid at the ratio of 65:35 % (v:v) with a flow rate of 1 mL/min and UV detection was carried out at 230 nm. Factors affecting the developed methods were studied and optimized and the retention times for BIS and ROS were found to be 2.758 and 4.974 min, respectively. Linearity of the proposed method was observed over a concentration range 0.2-50 μg/mL for each of BIS (r = 0.9999) and ROS (r = 0.9998). The proposed method was successfully applied for the determination of the studied drugs in their bulk powder, laboratory prepared mixtures and in the formulated tablets. The developed method is the first chromatographic method for determination of those drugs and showed no significant difference when compared with the reported methods.


Keywords


Tablets; RP-HPLC; Bisoprolol; Rosuvastatin; Chromatography; Novel formulation

Full Text:

PDF /    /


DOI: 10.5155/eurjchem.10.1.52-56.1815

Article Metrics


This Abstract was viewed 136 times | PDF Article downloaded 63 times

References

[1]. The British Pharmacopoeia, Volumes II and III, Her Majesty's Stationery Office, London, UK. 2009.

[2]. Sweetman, S. C.; Martindale, The complete drug reference, 2009. Thirty sixth editions, Pharmaceutical Press, Chicago, 2009.

[3]. United States Food and Drug Administration. Crestor (rosuvastatin calcium) Tablets. Prescribing Information Label. 2012; Available online: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s026lbl.pdf (accessed on 10 December 2018).

[4]. Bondjers, G.; Wiklund, O.; Wikstrand, J. Patent application number US 10/220, 790 Publication number US20030060477 A1, Publication date Mar 27, 2003. Available online (3 july 2017) at https://www.google.com/patents/US20030060477?cl=en10

[5]. Abdelwahab, N. S.; Ali, N. W.; Zaki, M. M.; Ali, A. A.; Abdelkawy, M. M. Eur. J. Chem. 2018, 9(4), 331-337.
https://doi.org/10.5155/eurjchem.9.4.331-337.1753

[6]. Salem, H. J. Pharm. Biomed. Anal. 2002, 29, 527-538.
https://doi.org/10.1016/S0731-7085(02)00100-0

[7]. Tuljarani, G.; Sankar, D. G.; Kadgapathi, P.; Suthakaran, R.; Satyanarayana, B. Int. J. Chem. Sci. 2010, 8, 2253-2258.

[8]. Shirkhedkar, A. A.; Thorve, R. R.; Surana, S. J. Pakistan J. Pharm. Sci. 2008, 21, 366-369.

[9]. Abdelmonem, A. A.; Ragab, H. G.; Hashem, H.; Bahgat, E. A. UK J. Pharm. Biosci. 2016, 4, 43-52.
https://doi.org/10.20510/ukjpb/4/i2/97093

[10]. Goyal, R. N.; Tyagi, A.; Bachheti, N.; Bishnoi, S. Electrochim. Acta 2008, 53, 2802-2808.
https://doi.org/10.1016/j.electacta.2007.10.057

[11]. Kakde, R. B.; Kotak, V. H.; Kale, D. L. Asian J. Res. Chem. 2008, 1, 70-73.

[12]. Pradip, N. B.; Emanual, M. P. J. Chromatogr. Sep. Tech. 2013, 4, 1-4.

[13]. Savita, S. Y.; Janhavi, R. R. Int. J. Pharm. Pharma Sci. 2013, 5, 286-290.

[14]. United States Pharmacopoeia, XXIV, United States Pharmacopoeia Convention, Washington, DC, 2007.

[15]. Shaikh, S.; Thusleem, O. A.; Muneera, M. S.; Akmal, J.; Kondaguli, A. V.; Ruckmani, K. A. J. Pharm. Biomed. Anal. 2008, 48, 1055-1057.
https://doi.org/10.1016/j.jpba.2008.08.009

[16]. Hefnawy, M. M.; Sultan, M. A.; Al-Shehri, M. M. J. Liq. Chromatogr. Relat. Technol. 2006, 29, 2901-2914.
https://doi.org/10.1080/10826070600978302

[17]. Athota, R. V.; Jagarlapudi, S. K.; Singampalli, M. R. Int. J. Pharm. Tech. Res. 2016, 9, 329-339.

[18]. Erdal, D.; Zehra, C. E.; Ghazal, R. J. Liq. Chromatogr. Relat . Technol. 2015, 38, 970-976.
https://doi.org/10.1080/10826076.2014.999200

[19]. Sevinc, K.; Paula, R. S. M.; Bengi, U.; Sibel, A. O. Chromatographia 2014, 77, 365-371.
https://doi.org/10.1007/s10337-013-2606-4

[20]. Tutunji, M. F.; Ibrahim, H. M.; Khabbas, M. H.; Tutunji, L. F. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2009, 877, 1689-1697.
https://doi.org/10.1016/j.jchromb.2009.04.021

[21]. Arjun, S.; Sivakumar, T.; Jain, D. A.; Umesh, M.; Arun, K. Y.; Tarun, S. Int. J. Pharm. Res. Dev. 2011, 3(3), 11-22.

[22]. Baldut, M.; Bonafede, S. L.; Petrone, L.; Simionato, L. D.; Segall, A. I. Adv. Res. 2015, 5, 1-8.
https://doi.org/10.9734/AIR/2015/19843

[23]. Rekha, R.; Anbazhagan, S.; Kumar, P. R. Int. J. Pharm. Tech. Res. 2012, 4, 1601-1605.

[24]. Jain, P. S.; Kale, N. K.; Surana, S. J. J. Pharm. Biosci. 2013, 4, 128-133.

[25]. Gupta, A.; Mishra, P.; Shah, K. E-J. Chem. 2009, 6(1), 89-92.

[26]. Garg, S. Acta Velit. 2014, 1, 20-24.

[27]. Alzoman, N. Z.; Sultan, M. A.; Maher, H. M.; Alshehri, M. M.; Wani, T. A.; Darwish, I. A. Molecules 2013, 18, 7711-7725
https://doi.org/10.3390/molecules18077711

[28]. Ramadan, A. A.; Mandil, H.; Alshelhawi, N. Int. J. Pharm. Pharma Sci. 2014, 6, 579-585.

[29]. Krishna, M. V.; Sankar, D. G. E- J. Chem. 2007, 4(1), 46-49.

[30]. Braga, V. S. M.; Mancilha, T. P.; Cassella, R. J.; Pacheco, W. F. J. Fluoresc. 2013, 23, 49-55.
https://doi.org/10.1007/s10895-012-1115-4

[31]. Nadia, M. M.; Amr, M. B.; Nesrine, T. L.; Abd El-Aleem, A. B. J. Liq. Chromatogr. Relat. Technol. 2014, 37, 2182-2196.
https://doi.org/10.1080/10826076.2013.828305

[32]. Sane, R.; Kamat, S.; Menon, S.; Inamdar, S.; Mote, M. J. Planar. Chromatogr. Mod. TLC. 2005, 18, 194-198.
https://doi.org/10.1556/JPC.18.2005.3.4

[33]. Ramadan, A. A.; Hussen, A.; Maktabi, M. Int. J. Pharm. Pharm. Sci. 2014, 6, 180-188.

[34]. Devi, S. U.; Latha, E. P.; Guptha, C. V. N. K.; Ramalingam, P. Int. J. Pharma Bio. Sci. 2011, 2, 134-140.

[35]. Shekhar, M. C.; Babu, G. R.; Dinda, S. C.; Sonthosh, P. V.; Shwetha, P. Int. J. Pharm. 2014, 4, 335-339.

[36]. Palvai, S.; Seelam, S. C.; Dhanalakshmi, K.; Reddy, N. Int. J. Pharm. Therap. 2013, 4, 182-187.

[37]. Caglar, S .; Toker, S. J. Chrom. Sci. 2013, 51, 53-58.
https://doi.org/10.1093/chromsci/bms105

[38]. Turabi, Z. M.; O'hood, A. K. ‎Int. J. Pharm. Sci. Drug Res. 2014, 6, 154-159.

[39]. Wang, B.; Choudhry, N. K.; Gagne, J. J.; Landon, J.; Kesselheim, A. S.; Am. Heart J. 2015, 169(3), 379-386.
https://doi.org/10.1016/j.ahj.2014.12.014

[40]. Banker, G.; Anderson, N. R. Tablets, The Theory and Practice of Industnal pharmacy, 3rd Ed., Lachman, L.; Liberman, H. A.; Kanig, J. K. (ed.), Lea-Febiger, Philadelphia, pp. 294, 1986

[41]. Fiese, E. F.; Hagen, T. A. Preformulation, The Theory and Practice of Industnal pharmacy, 3rd Ed., Lachman, L.; Liberman, H. A.; Kanig, J. K. (ed.), Lea-Febiger, Philadelphia, pp. 171, 1986.

[42]. Bakan, J. A. Capsules, The Theory and Practice of Industnal pharmacy, 3rd Ed., Lachman, L.; Liberman, H. A.; Kanig, J. K. (ed.), Lea-Febiger, Philadelphia, pp. 412, 1986.

[43]. International Conference on Harmonization Q2 (R1), Validation of Analytical Procedures: Text and Methodology, ICH Harmonized Tripartite Guideline, 2005.


How to cite


Zaki, M.; Abdelwahab, N.; Ali, A.; Sharkawi, S. Eur. J. Chem. 2019, 10(1), 52-56. doi:10.5155/eurjchem.10.1.52-56.1815
Zaki, M.; Abdelwahab, N.; Ali, A.; Sharkawi, S. Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC. Eur. J. Chem. 2019, 10(1), 52-56. doi:10.5155/eurjchem.10.1.52-56.1815
Zaki, M., Abdelwahab, N., Ali, A., & Sharkawi, S. (2019). Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC. European Journal of Chemistry, 10(1), 52-56. doi:10.5155/eurjchem.10.1.52-56.1815
Zaki, Marco, Nada Sayed Abdelwahab, Adel Ahmed Ali, & Souty Mounie Zaki Sharkawi. "Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC." European Journal of Chemistry [Online], 10.1 (2019): 52-56. Web. 16 Sep. 2019
Zaki, Marco, Abdelwahab, Nada, Ali, Adel, AND Sharkawi, Souty. "Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC" European Journal of Chemistry [Online], Volume 10 Number 1 (31 March 2019)

DOI Link: https://doi.org/10.5155/eurjchem.10.1.52-56.1815

Refbacks

  • There are currently no refbacks.




Copyright (c) 2019 Authors

Creative Commons License
This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at http://www.eurjchem.com/index.php/eurjchem/pages/view/terms and incorporate the Creative Commons Attribution-Non Commercial (CC BY NC) (International, v4.0) License (http://creativecommons.org/licenses/by-nc/4.0). By accessing the work, you hereby accept the Terms. This is an open access article distributed under the terms and conditions of the CC BY NC License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited without any further permission from Atlanta Publishing House LLC (European Journal of Chemistry). No use, distribution or reproduction is permitted which does not comply with these terms. Permissions for commercial use of this work beyond the scope of the License (http://www.eurjchem.com/index.php/eurjchem/pages/view/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).


© Copyright 2019  Atlanta Publishing House LLC All Right Reserved.

The opinions expressed in all articles published in European Journal of Chemistry are those of the specific author(s), and do not necessarily reflect the views of Atlanta Publishing House LLC, or European Journal of Chemistry, or any of its employees.

Copyright 2019 Atlanta Publishing House LLC. All rights reserved. This site is owned and operated by Atlanta Publishing House LLC whose registered office is 4614 Lavista road, Tucker, GA, 30084, USA. Registered in USA.