European Journal of Chemistry

Novel approach for UPLC-ESI-Tandem mass spectrometric method for simultaneous determination of olmesartan medoxomil and hydrochlorothiazide in their pharmaceutical combination with kinetic studies of forced degradation



Main Article Content

Ahmed Abdalazim Mostafa
Maha Mahmoud Abou-El Alamin

Abstract

A simple, robust ultra-performance liquid chromatography coupled to ESI-Tandem mass spectrometric (UPLC-MS/MS) technique was developed for the simultaneous quantitation of olmesartan medoxomil (OLM) and hydrochlorothiazide (HCT) in bulk and their combined pharmaceutical formulation. Chromatographic separation was done on a Hypersil gold 50×2.1 mm (1.9 μm) column, with gradient elution of mobile phase consisted of acetonitrile and 0.1% formic acid aqueous solution. Detection of analytes was carried out using selective reaction monitoring (SRM) mode on a triple quadrupole mass spectrometer coupled with electrospray ionization (ESI). Linearity was achieved over concentration ranges of 2.0-200.0 and 3.0-50.0 ng/mL for OLM and HCT, respectively. Intra and inter day reproducibility were acceptable. The lower limits of detection were found to be 0.627 and 0.583 ng/mL and lower limits of quantitation were 1.900 and 1.767 ng/mL for OLM and HCT, respectively. The method was successfully applied for determination the cited drugs in their combined pharmaceutical dosage form. The method was applied to study the kinetic of forced degradation of both drugs under different conditions. The method was validated according to ICH guidelines and there is no significance difference between the proposed method and the reported method. The simplicity and sensitivity of this method allows the utilization of method in quality control of the cited drugs.


icon graph This Abstract was viewed 1673 times | icon graph Article PDF downloaded 660 times

How to Cite
(1)
Mostafa, A. A.; Abou-El Alamin, M. M. Novel Approach for UPLC-ESI-Tandem Mass Spectrometric Method for Simultaneous Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Their Pharmaceutical Combination With Kinetic Studies of Forced Degradation. Eur. J. Chem. 2016, 7, 309-314.

Article Details

Share
Crossref - Scopus - Google - European PMC
References

[1]. Bramlage, P.; Zemmrich, C.; Ketelhut, R.; Wolf, W. P.; Fronk, E. M.; Schmieder, R. E. Vasc. Health Risk Manag. 2013, 9, 475-483.
http://dx.doi.org/10.2147/VHRM.S49118

[2]. Mohan, J. C.; Jain, R.; Chamle, V.; Bhargava, A. J. Clin. Diagn. Res. 2015, 9(8), OC10-3.

[3]. Chrysant, S. G.; Weber, M. A.; Wang, A. C.; Hinman, D. J. Am. Soc. Hypertens 2004, 17, 252-259.
http://dx.doi.org/10.1016/j.amjhyper.2003.11.003

[4]. Sellin, L.; Stegbauer, J.; Laeis, P.; Rump, L. C. J. Hyperten. 2005, 23, 2083-2092.
http://dx.doi.org/10.1097/01.hjh.0000186022.74245.01

[5]. Laeis, P.; Püchler, K.; Kirch, W. J. Hypertens Suppl. 2001, 19(1), S21-32.
http://dx.doi.org/10.1097/00004872-200106001-00004

[6]. Rote, A. R.; Bari, P. D. Indian J. Pharm. Sci. 2010, 72, 111-113.
http://dx.doi.org/10.4103/0250-474X.62245

[7]. Merey, H. A.; Ramadan, N. K.; Diab, S. S.; Moustafa, A. A. Spectrochim. Acta A 2014, 125, 138-146.
http://dx.doi.org/10.1016/j.saa.2014.01.095

[8]. Darwish, H. W. Chem. Cent. J. 2013, 7, 22-22.
http://dx.doi.org/10.1186/1752-153X-7-22

[9]. Solanki, T. B.; Shah, P. A.; Patel, K. G. Indian J. Pharm. Sci. 2014, 76, 179-187.

[10]. Verma, P. K.; Kamboj, V. K. Pak. J. Pharm. Sci. 2013, 26(1), 209-215.

[11]. Vidyadhara, S.; Reddyvalam, L. C. S.; Rao, B. V.; Tejaswi, K.; Reshma, M. Oriental J. Chem. 2014, 30(1), 195-201.

[12]. Yunoos, M.; Sankar, D. G. Int. J. Pharm. Sci. Drug. Res. 2015, 7(3), 290-297.

[13]. Srikanth, R. R.; Murali, K. R.; Vekaria, N. A.; Rao, S. V.; Mantena, B. P. V. J. Chromatogr. B. 2015, 38, 1343-1354.

[14]. Gorain, B.; Choudhury, H.; Biswas, E.; Barik, A.; Jaisankar, P.; Pal, T. K. RSC Advances 2013, 3, 10887-10893.
http://dx.doi.org/10.1039/c3ra41452c

[15]. Kumar, A.; Verma, P. R. P.; Monif, T.; Khuroo, A. H.; Iyer, S. S.; Singh, A. K. J. Chromatogr. B. 2012, 35, 59-78.

[16]. Chae, J. W.; Baek, I. H.; Seo, J. W.; Jung, S. H.; Back, H. M.; Song, B. J.; Lee, B. Y.; Yun, H. Y.; Kang, W.; Kwon, K. I. Int. J. Clin. Pharmacol. Ther. 2014, 52(8), 676-683.
http://dx.doi.org/10.5414/CP202046

[17]. Ebeid, W. M.; Elkady, E. F.; El-Zaher, A. A.; El-Bagary, R. I.; Patonay, G. Anal. Bioanal. Chem. 2014, 406, 6701-6712.
http://dx.doi.org/10.1007/s00216-014-8085-0

[18]. Kumar, K. K.; Rao, C. K.; Madhusudan, G.; Mukkanti, K. Am. J. Analyt. Chem. 2012, 3, 50-58.
http://dx.doi.org/10.4236/ajac.2012.31008

[19]. Jain, P. S.; Patel, M. K.; Gorle, A. P.; Chaudhari, A. J.; Surana, S. J. J. Chromatogr. Sci. 2012, 50, 680-687.
http://dx.doi.org/10.1093/chromsci/bms067

[20]. Mowaka, S.; Mohamed, D. RSC Advances 2015, 5, 60467-60481.
http://dx.doi.org/10.1039/C5RA11448A

[21]. Mohamed, D; Mowaka, S.; Mostafa, A. Eur. J. Chem. 2014, 5, 181-85.
http://dx.doi.org/10.5155/eurjchem.5.1.181-185.942

[22]. ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2(R1), Current Step 4 Version, Parent Guidelines on Methodology, 2005.

[23]. Shrivastava, A.; Gupta, V. Methods for the determination of limit of detection and limit of quantitation of the analytical methods, 2011; Vol. 2.

[24]. El-Gizawy, S. M.; Abdelmageed, O. H.; Omar, M. A.; Deryea, S. M.; Abdel-Megied, A. M. Am. J. Analyt. Chem. 2012, 3, 422-430.
http://dx.doi.org/10.4236/ajac.2012.36055

[25]. Adamovics, J. A. Chromatographic analysis of pharmaceuticals; Marcel Dekker Inc., New York, 1997.

[26]. ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2 (R1), Current Step 4 Version, Parent Guidelines on Methodology Dated November 6; 1996, incorporated in November 2005.

[27]. Murakami, T.; Konno, H.; Fukutsu, N.; Onodera, M.; Kawasaki, T.; Kusu, F. J. Pharm. Biomed. Anal. 2008, 47, 553-559.
http://dx.doi.org/10.1016/j.jpba.2008.02.021

[28]. Mahajan, A. A.; Thaker, A. K.; Mohanraj, K. J. Brazilian Chem. Soc. 2012, 23, 445-452.

[29]. Gorog, S. J. Pharm. Biomed. Anal. 2008, 48, 247-253.
http://dx.doi.org/10.1016/j.jpba.2007.10.038

[30]. Florence, D. A. A. T. Physicochemical Principles of Pharmacy, Macmillan Press, London 1998.
http://dx.doi.org/10.1007/978-1-349-14416-7

Supporting Agencies

The Pharmaceutical Services Centre and LC-MS Unit, Faculty of Pharmacy, Helwan University, Cairo, Egypt
TrendMD

Dimensions - Altmetric - scite_ - PlumX

Downloads and views

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
License Terms

License Terms

by-nc

Copyright © 2024 by Authors. This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at https://www.eurjchem.com/index.php/eurjchem/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 (https://www.eurjchem.com/index.php/eurjchem/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).