

Different spectrophotometric and TLC-densitometric methods for determination of olmesartan medoxomil and hydrochlorothiazide and their degradation products
Selvia Maged Adly (1,*)




(1) Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., Beni-Suef 62514, Egypt
(2) Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., Beni-Suef 62514, Egypt
(3) Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., Beni-Suef 62514, Egypt
(4) Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., Beni-Suef 62514, Egypt
(*) Corresponding Author
Received: 31 Aug 2018 | Revised: 07 Oct 2018 | Accepted: 10 Oct 2018 | Published: 31 Dec 2018 | Issue Date: December 2018
Abstract
In this work, multivariate calibration models and TLC-densitometric methods have been developed and validated for quantitative determination of olmesartan medoxomil (OLM) and hydrochlorothiazide (HCZ) in presence of their degradation products, olmesartan (OL) and salamide (SAL), respectively. In the first method, multivariate calibration models including principal component regression (PCR) and partial least square (PLS) were applied. The wavelength range 210-343 nm was used and data was auto-scaled and mean centered as pre-processing steps for PCR and PLS models, respectively. These models were tested by application to external validation set with mean percentage recoveries 99.78, 100.01, 100.41 and 100.46% for OLM, HCZ, OL and SAL, respectively, for PLS model and also, 100.22, 100.40, 102.25 and 100.13% for them, respectively, for PCR model. The second method is TLC-densitometry at which the chromatographic separation was carried out using silica gel 60F254 TLC plates and the developing system consisted of a mixture of ethyl acetate:chloroform:methanol: formic acid:tri-ethylamine (60:40:4:4:1, by volume) with UV-scanning at 254 nm. The developed methods were successfully applied for determination of OLM and HCZ in their pharmaceutical dosage form. Also, statistical comparison was made between the developed methods and the reported method using student’s-t test and F-test and results showed that there was no significant difference between them concerning both accuracy and precision.
Announcements
One of our sponsors will cover the article processing fee for all submissions made between May 17, 2023 and June 16, 2023 (Voucher code: SPONSOR2023).
Editor-in-Chief
European Journal of Chemistry
Keywords
Full Text:
PDF

DOI: 10.5155/eurjchem.9.4.400-407.1784
Links for Article
| | | | | | |
| | | | | | |
| | | |
Related Articles
Article Metrics


Funding information
BIG Pharma Company, Sabaa Co., Cairo, Egypt.
Citations
[1]. Nada S Abdelwahab, Selvia M Adly, Nourudin W Ali, Maha M Abdelrahman
Development and Validation of Two Novel Chromatographic Methods: HPTLC and HPLC for Determination of Bromhexine Hydrochloride in Presence of Its Two Impurities
Journal of Chromatographic Science 59(5), 425, 2021
DOI: 10.1093/chromsci/bmaa132

[2]. Maha M. Abdelrahman, Selvia M. Adly, Nourudin W. Ali, Nada S. Abdelwahab
Development and Validation of Different Spectrophotometric and High-Performance Thin-Layer Chromatographic Methods for the Determination of Fosinopril Sodium, Hydrochlorothiazide, and Chlorothiazide as Hydrochlorothiazide Impurity
JPC - Journal of Planar Chromatography - Modern TLC 32(5), 411, 2019
DOI: 10.1556/1006.2019.32.5.9

[3]. Mahmoud Mohamed Abbas, Amira Mabrouk El-Kosasy, Lobna Abd El-Aziz Hussein, Nancy Magdy Hanna
Universal procedures for spectrophotometric determination of anticoccidial drugs; application to multi-ingredient veterinary formulation and computational investigations for multivariate analysis
European Journal of Chemistry 12(4), 368, 2021
DOI: 10.5155/eurjchem.12.4.368-376.2144

[4]. Heba Elmansi, Fathalla Belal, Mervat M.Hosny, Omar M.EL-Abassy
Utility of NBD-Cl as an electrophilic reagent for the determination of the two antihypertensive drugs hydrochlorothiazide and minoxidil in dosage forms and human urine samples
Chemical Papers 75(5), 1925, 2021
DOI: 10.1007/s11696-020-01457-y

[5]. Mohamed M. Al-Sanea, Mohamed A. Abdelgawad, Khalid S. Alharbi, Selvia M. Adly, Nada S. Abdelwahab, Nourudin W. Ali, Maha M. Abdelrahman
Simultaneous analysis of several antihypertensive drugs in different combinations: Application for determination of drug degradation products and process impurities
Microchemical Journal 166, 106203, 2021
DOI: 10.1016/j.microc.2021.106203

[6]. Amitkumar J. Vyas, Dhruvanshi A. Gol, Riddhi G. Usdad, Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Alpesh Chudasama
HPTLC-Densitometric Method for Simultaneous Estimation of Olmesartan medoxomil and Chlorthalidone in Tablet Dosage Form
Analytical Chemistry Letters 10(4), 498, 2020
DOI: 10.1080/22297928.2020.1814859

References
[1]. British Pharmacopoeia, Standard 19. 0, Complete edition USB. ed.; London, the Stationery Office Norwich, 2014; Vol. 1.
[2]. Moussa, B.; Mohamed, M.; Youssef, N. J. Chilean Chem. Soc. 2010, 55(2), 199-202.
https://doi.org/10.4067/S0717-97072010000200011
[3]. Mollica, J. A.; Rehm, C. R.; Smith, J. B. J. Pharm. Sci. 1969, 58(5), 635-636.
https://doi.org/10.1002/jps.2600580531
[4]. Brigante, M.; DellaGreca, M.; Previtera, L.; Rubino, M.; Temussi, F. Environ. Chem. Lett. 2005, 2(4), 195-198.
https://doi.org/10.1007/s10311-004-0096-1
[5]. Greathouse, M. Vasc. Health Risk Man. 2006, 2(4), 401-409.
https://doi.org/10.2147/vhrm.2006.2.4.401
[6]. Bhusari, K. P.; Khedekar, P. B.; Dhole, S.; Banode, V. S. Indian J. Pharm. Sci. 2009, 71(5), 505-508.
https://doi.org/10.4103/0250-474X.58176
[7]. Jadhav, J. V.; Burade, K. Der Pharma Chemica 2013, 5(4), 252-261.
[8]. Hemke, A. T.; Bhure, M. V.; Chouhan, K. S.; Gupta, K. R.; Wadodkar, S. G. E-J. Chem. 2010, 7(4), 1156-1161.
[9]. Kachave, R. N.; Bhadane, R. N.; Wagh, R.; Jain, D. Res. J. Pharm. Technol. 2010, 3(4), 1047-1049.
[10]. Rote, A. R.; Bari, P. D. Indian J. Pharm. Sci. 2010, 72(1), 111-113.
https://doi.org/10.4103/0250-474X.62245
[11]. Rote, A. R.; Bari, P. D. AAPS Pharm. Sci. Tech. 2009, 10(4), 1200-1205.
https://doi.org/10.1208/s12249-009-9318-y
[12]. Singh, G. A. Intern. J. Pharm. Erud. 2011, 1(1), 1-8.
[13]. Farouk, M.; Abd-El-Aziz, O.; Hemdanb, A.; Shehata, M. J. Am. Sci. 2011, 7(1), 300-312.
[14]. Celebier, M.; Altinoz, S. Hacettepe Univ. J. Fac. Pharm. 2007, 27(2), 119-130.
[15]. Bari, P. D.; Rote, A. R. Chromatographia 2009, 69(11), 1469-1472.
https://doi.org/10.1365/s10337-009-1094-z
[16]. Ilango, K.; Kumar, P. S. J. Anal. Met. Chem. 2013, 2013, 1-8.
[17]. Kadukar, S.; Gandhi, S.; Ranjane, P.; Ranher, S. J. Planar Chromatog. Modern TLC 2009, 22(6), 425-428.
[18]. Shah, N.; Suhagia, B.; Shah, R.; Patel, N. Indian J. Pharm. Sci. 2007, 69(6), 834-836.
https://doi.org/10.4103/0250-474X.39447
[19]. Kumar, A. J.; Sathya, A.; Kumar, S. K.; Sagar, P. N.; Prathap, B.; Lokesh, S. B.; Gopal, V. Inter. J. Res. Pharm. Sci. 2016, 1(1), 24-27.
[20]. Kurbanoglu, S.; Gumustas, M.; Ozkan, S. A. J. Pharm. Biomed. Anal. 2013, 72(C), 198-201.
https://doi.org/10.1016/j.jpba.2012.08.018
[21]. Lata, K.; Tomar, V.; Mittal, V.; Hooda, A.; Jalwal, P. Inter. J. Pharm. Qual. Assur. 2010, 2(1), 60-66.
[22]. Lei, X.; Zeng, Z.; Liu, T.; Lu, H.; He, C.; Zhong, X. Chinese J. Clin. Pharm. 2010, 2, 11-16.
[23]. Hasan, M.; Masud, A. A.; Ahmed, J. Int. J. Pharm. Sci. Res. 2010, 1(12), 80-84.
[24]. Devanaboyina, N.; Satyanarayana, T.; Rao, B. G. Int. J. Pharma. Bio. Sci. 2012, 3(2), 107-115.
[25]. Ritihaas, C. S.; Prakash, B. B. Int. J. Pharma. Bio. Sci. 2015, 6(1), 180-187.
[26]. Raja, B.; Rao, A. L. Int. J. Res. Pharm. Chem. 2011, 1(3), 714-717.
[27]. Rudrapal, M.; Oduri, M. U.; Samidala, N. R.; Kiran, B. S.; Junejo, J. A.; Singh, K. D. Orient. J. Chem. 2015, 31(2), 921-926.
https://doi.org/10.13005/ojc/310236
[28]. Gayathri, S.; Sireesha, D.; Haque, M. A.; Harshini, S.; Bhakshi, V.; Reddy, S. K. Int. J. Pharma. Res. Health Sci. 2014, 2(6), 457-462.
[29]. Sagirli, O.; Onal, A.; Toker, S. E.; Sensoy, D. Chromatographia 2007, 66(3), 213-218.
https://doi.org/10.1365/s10337-007-0304-9
[30]. Saravanan, G.; Bajidbhee, S.; Krishnanjaneyulu, I. Asian J. Res. Chem. 2015, 8(2), 147-152.
[31]. Vidyadhara, S.; Sasidhar, R. L. C.; Rao, B. V.; Tejaswi, K.; Reshma, M. Orient. J. Chem. 2014, 30(1), 195-201.
https://doi.org/10.13005/ojc/300123
[32]. Mostafa, A. A.; Alamin, M. M. A. E. Eur. J. Chem. 2016, 7, 309-314.
https://doi.org/10.5155/eurjchem.7.3.309-314.1450
[33]. Dinc, E.; Ertekin, Z. C. Talanta 2016, 148(C), 144-152.
https://doi.org/10.1016/j.talanta.2015.10.074
[34]. Kumar, A.; P. Verma, P. R.; Monif, T.; Khuroo, A. H.; Iyer, S. S. Clin. Res. Regul. Affairs 2014, 31(1), 6-23.
https://doi.org/10.3109/10601333.2013.849267
[35]. Kumar, A.; Verma, P. R. P.; Monif, T.; Khuroo, A. H.; Iyer, S. S.; Singh, A. K. J. Liquid Chromatog. Rel. Tech. 2012, 35(1), 59-78.
https://doi.org/10.1080/10826076.2011.597060
[36]. Liu, D.; Jiang, J.; Wang, P.; Feng, S.; Hu, P. J. Chromatog. B 2010, 878(9), 743-748.
https://doi.org/10.1016/j.jchromb.2010.01.009
[37]. Jianfeng, Z. China Licensed Pharm. 2012, 7, 9-14.
[38]. Mali, A. D.; More, U. B.; More, U. B. Int. J. Pharm. Pharm. Sci. 2016, 8(5), 45-48.
[39]. Patel, U.; Chokshi, A.; Desai, P. Int. J. Pharm. Pharm. Sci. 2014, 6(9), 318-323.
[40]. Reddy, S.; Krishna, M. R.; Vekaria, N.; Rao, S. V.; Mantena, B. P. J. Liquid Chromatog. Rel. Tech. 2015, 38(13), 1343-1354.
https://doi.org/10.1080/10826076.2015.1048877
[41]. Moussa, B.; Mohamed, M.; Youssef, N. J. Planar Chromatog. Modern TLC 2011, 24(1), 35-39.
[42]. Raj, N. D.; Anbazhagan, S.; Babu, K. A.; Babu, S. N.; Bhimanadhuni, C. N. Int. Curr. Pharm. J. 2012, 1(11), 336-341.
https://doi.org/10.3329/icpj.v1i11.12058
[43]. Godse, V. P.; Bafana, Y. S.; Borkar, D. D.; Bhosale, A. V. Eurasian J. Anal. Chem. 2010, 5(2), 137-144.
[44]. Hansen, P. C. Num. Algorith. 2007, 46(2), 189-194.
https://doi.org/10.1007/s11075-007-9136-9
[45]. Vasanti, S.; Sulabha, S. Drug Invent. Today 2009, 1(2), 81-88.
[46]. Otto, M., Chemometrics: Statistics and Computer Application in Analytical Chemistry, Weinheim: Wiley-VCH, 1999.
[47]. Abdelaleem, E. A.; Abdelwahab, N. S. Chem. Central J. 2012, 6(1), 27-35.
https://doi.org/10.1186/1752-153X-6-27
[48]. Abdelkawy, M.; Metwaly, F.; El Raghy, N.; Hegazy, M.; Fayek, N. J. Chromatogr. Sep. Tech. 2011, 2(112), 2-11.
[49]. Ali, N. W.; Abdelwahab, N. S.; Abdelrahman, M. M.; El-Zeiny, B. A.; Tohamy, S. I. Anal. Chem. Lett. 2016, 6(6), 706-717.
https://doi.org/10.1080/22297928.2016.1246199
[50]. Habib, N. M.; Abdelrahman, M. M.; Abdelwhab, N. S.; Ali, N. W. Anal. Chem. Lett. 2017, 7(1), 97-108.
https://doi.org/10.1080/22297928.2017.1294990
[51]. Naguib, I. A.; Abdelrahman, M. M.; El Ghobashy, M. R.; Ali, N. A. J. AOAC Inter. 2016, 99(2), 386-395.
https://doi.org/10.5740/jaoacint.15-0286
[52]. Hussien, L. A.; Abdel Ghani, M. F.; Abo El Alamein, A. M.; Mohamed, E. H. Eur. J. Chem. 2014, 5(2), 311‐320.
https://doi.org/10.5155/eurjchem.5.2.311-320.951
[53]. Habib, N. M.; Ali, N. W.; Abdelwhab, N. S.; Abdelrahman, M. M. Bull. Fac. Pharm. Cairo Univ. 2017, 55(1), 185-194.
https://doi.org/10.1016/j.bfopcu.2017.02.004
[54]. Habib, N. M.; Abdelwhab, N. S.; Abdelrahman, M. M.; Ali, N. W. Anal. Chem. Lett. 2015, 5(6), 399-409.
https://doi.org/10.1080/22297928.2016.1142895
[55]. Abdelrahman, M. M.; Naguib, I. A.; El Ghobashy, M. R.; Ali, N. J. Chromatog. Sci. 2018, 56(4), 317-326.
https://doi.org/10.1093/chromsci/bmx114
[56]. Ali, N. W.; Abbas, S. S.; Zaazaa, H. E.; Abdelrahman, M. M.; Abdelkawy, M. J. Pharm. Anal. 2012, 2(2), 105-116.
https://doi.org/10.1016/j.jpha.2011.11.004
[57]. Branch, S. K. J. Pharm. Biomed. Anal. 2005, 38(5), 798-805.
https://doi.org/10.1016/j.jpba.2005.02.037
[58]. Fried, B.; Sherma, J. Thin-Layer Chromatography, 4th Edition ed., New York. Basel., Marcel Dekker, Inc., 1999.
How to cite
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.9.4.400-407.1784

















European Journal of Chemistry 2018, 9(4), 400-407 | doi: https://doi.org/10.5155/eurjchem.9.4.400-407.1784 | Get rights and content
Refbacks
- There are currently no refbacks.
Copyright (c) 2018 Authors

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 - 2023 • 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 2010-2023 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.