European Journal of Chemistry 2016, 7(3), 309-314. doi:10.5155/eurjchem.7.3.309-314.1450

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


Ahmed Abdalazim Mostafa (1,*) , Maha Mahmoud Abou-El Alamin (2)

(1) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Helwan University, 11795, Cairo, Egypt
(2) Analytical Chemistry Department, Faculty of Pharmacy, Helwan University, 11795, Cairo, Egypt
(*) Corresponding Author

Received: 11 May 2016, Accepted: 02 Jul 2016, Published: 30 Sep 2016

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.


Keywords


UPLC; Olmesartan; Hydrochlorothiazide; Kinetic degradation; Pharmaceutical dosage form; Tandem mass spectrometric technique

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DOI: 10.5155/eurjchem.7.3.309-314.1450

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[1]. Selvia Maged Adly, Maha Mohamed Abdelrahman, Nada Sayed Abdelwahab, Nourudin Wageh Ali
Different spectrophotometric and TLC-densitometric methods for determination of olmesartan medoxomil and hydrochlorothiazide and their degradation products
European Journal of Chemistry  9(4), 400, 2018
DOI: 10.5155/eurjchem.9.4.400-407.1784
/


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How to cite


Mostafa, A.; Abou-El Alamin, M. Eur. J. Chem. 2016, 7(3), 309-314. doi:10.5155/eurjchem.7.3.309-314.1450
Mostafa, A.; Abou-El Alamin, 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(3), 309-314. doi:10.5155/eurjchem.7.3.309-314.1450
Mostafa, A., & Abou-El Alamin, M. (2016). 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. European Journal of Chemistry, 7(3), 309-314. doi:10.5155/eurjchem.7.3.309-314.1450
Mostafa, Ahmed, & Maha Mahmoud Abou-El Alamin. "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." European Journal of Chemistry [Online], 7.3 (2016): 309-314. Web. 22 Sep. 2019
Mostafa, Ahmed, AND Abou-El Alamin, Maha. "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" European Journal of Chemistry [Online], Volume 7 Number 3 (30 September 2016)

DOI Link: https://doi.org/10.5155/eurjchem.7.3.309-314.1450

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