European Journal of Chemistry 2019, 10(1), 52-56 | doi: https://doi.org/10.5155/eurjchem.10.1.52-56.1815 | Get rights and content






  OPEN ACCESS | PEER-REVIEWED | RESEARCH ARTICLE | DOWNLOAD PDF | VIEW FULL-TEXT PDF | TOTAL VIEWS

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 | Revised: 13 Dec 2018 | Accepted: 18 Dec 2018 | Published: 31 Mar 2019 | Issue Date: March 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

Links for Article


| | | | | | |

| | | | | | |

Related Articles




Article Metrics

This Abstract was viewed 461 times | PDF Article downloaded 134 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. 8 Jul. 2020
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)

The other citation formats (EndNote | Reference Manager | ProCite | BibTeX | RefWorks) for this article can be found online at: How to cite item


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

| | | | | | |

| | | | | |

Save to Zotero Save to Mendeley



European Journal of Chemistry 2019, 10(1), 52-56 | doi: https://doi.org/10.5155/eurjchem.10.1.52-56.1815 | Get rights and content

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 2010 - 2020  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 2010-2020 Atlanta Publishing House LLC. All rights reserved. This site is owned and operated by Atlanta Publishing House LLC whose registered office is 2850 Smith Ridge Trce Peachtree Cor GA 30071-2636, USA. Registered in USA.

hatay escort hatay escort corlu escort corum escort burgaz escort giresun escort aydin escort ordu escort erzincan escort hatay escort sivas escort rize escort edirne escort aksaray escort kibris escort isparta escort erzurum escort tekirdag escort usak escort urfa escort kastamonu escort kibris escort manisa escort giresun escort urfa escort nevsehir escort sivas escort yalova escort ordu escort hatay escort yalova escort amasya escort kayseri escort ordu escort maras escort canakkale escort yalova escort balikesir escort manisa escort urfa escort mugla escort trabzon escort bolu escort corlu escort diyarbakir escort isparta escort kutahya escort elazig escort erzurum escort sakarya escort afyon escort kutahya escort konya escort agri escort cesme escort sinop escort sivas escort konya escort kibris escort adapazari escort luleburgaz escort adana escort kibris escort rize escort sakarya escort alanya escort isparta escort burdur escort konya escort bitlis escort canakkale escort sivas escort amasya escort mus escort aydin escort van escort yalova escort kastamonu escort mardin escort bolu escort afyon escort sakarya escort isparta escort tokat escort trakya escort bayburt escort urfa escort mardin escort