

Derivative spectrophotometric method for simultaneous determination of ezetimibe and simvastatin in combined tablets
Bahia Abbas Moussa (1)



(1) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo, EG-115562, Egypt
(2) National Organization for Drug Control and Research (NODCAR), Cairo, EG-12553, Egypt
(3) National Organization for Drug Control and Research (NODCAR), Cairo, EG-12553, Egypt
(*) Corresponding Author
Received: 15 May 2010 | Revised: 24 Aug 2010 | Accepted: 20 Sep 2010 | Published: 22 Dec 2010 | Issue Date: December 2010
Abstract
The introduced study portrays the development and validation of an effortless, speedy and selective first order derivative zero-crossing spectrophotometric method to estimate ezetimibe and simvastatin simultaneously in combined drug products over and above in the presence of ezetimibe alkaline degradation products. Ezetimibe and its alkaline degradates spectra showed zero-crossing point at 249 nm, so the amplitude at 249 nm could be used for calculating the concentration of simvastatin. While simvastatin and ezetimibe alkaline degradates spectra showed a zero-reading value at 261 nm, so ezetimibe could be determined by measuring the amplitude at 261 nm. Regression plots revealed good linear relationships in the concentration range 1-16 µg/mL with accuracy checked by conducting recovery studies; average recovery was 99.61 ± 1.183 and 100.47 ± 1.310 for ezetimibe and simvastatin, respectively. The suggested first derivative spectrophotometric method was successfully applied for the determination of the cited drugs in "Inegy 10/10, 10/20 and 10/40 tablets". Satisfactory results were obtained for the recovery of both drugs and were in good agreement with the labeled amounts. Method validation was estimated according to USP guidelines.
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DOI: 10.5155/eurjchem.1.4.348-351.110
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Citations
[1]. Ashraf Abdel-Fattah
Bivariate and Multivariate Spectrophotometric Methods for Determination of Ezetimibe with Kinetic Study of Its Alkaline Degradation
Journal of Analytical & Pharmaceutical Research 3(1), , 2016
DOI: 10.15406/japlr.2016.03.00042

[2]. Nancy Magdy, Miriam F. Ayad
Two smart spectrophotometric methods for the simultaneous estimation of Simvastatin and Ezetimibe in combined dosage form
Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 137, 685, 2015
DOI: 10.1016/j.saa.2014.08.042

[3]. Hassan R.H. Ali, Niveen A. Mohamed, Ahmed Faried Abdel Hakiem
Facile determination of ezetemibe and either atorvastatin or simvastatin by Fourier transform infrared spectroscopy
Vibrational Spectroscopy 115, 103273, 2021
DOI: 10.1016/j.vibspec.2021.103273

[4]. Fathalla Belal, Mohamed Walash, Nahed El-Enany, Sahar Zayed
Development and Validation of GC-MS and HPLC Methods for the Determination of Simvastatin in Tablets and Human Urine
Analytical Chemistry Letters 8(5), 713, 2018
DOI: 10.1080/22297928.2018.1515658

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