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Stability-indicating HPLC and PLS chemometric methods for the determination of acemetacin in presence of its degradation products and impurities
Amira Mohamed Kessiba (1,*)
, Maha Abdel Monen Hegazy (2) , Mohamed Mohamed Abdelkawy (3) , Ahmed Emad El Gendy (4) (1) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Misr International University, KM 28, Cairo, Egypt
(2) Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt
(3) Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt
(4) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Misr International University, KM 28, Cairo, Egypt
(*) Corresponding Author
Received: 23 Aug 2015 | Accepted: 19 Sep 2015 | Published: 31 Dec 2015 | Issue Date: December 2015
Abstract
Two stability-indicating methods were developed and validated for the quantitative determination of acemetacin (ACM) in presence of its degradation products and impurities. The first method was based on separation of ACM from its degradation products and impurities by RP-HPLC on Inertsil C8 column (150 × 4.6 mm i.d) using a mobile phase composed of 0.02 M phosphate buffer: methanol (35:65, v:v, pH = 6.5). The flow rate was adjusted at 1 mL/min and quantification was achieved with UV detection at 245 nm using meloxicam as internal standard. The second method was based on multivariate spectrophotometric analysis using partial least square regression model. The drug was subjected to acid, base, oxidative and thermal stress conditions and the degradation products were identified. The developed methods have the requisite accuracy, selectivity, sensitivity and precision to assay ACM in presence of its degradation products and impurities either in bulk powder or in pharmaceutical dosage form. The results obtained for the analysis of ACM in its pure form by the proposed methods were statistically compared to those obtained by applying a reported HPLC method. The statistical comparison showed that there is no significant difference between the proposed methods and the reported one with respect to accuracy and precision.
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DOI: 10.5155/eurjchem.6.4.422-429.1313
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Citations
[1]. Maha Mahmoud Abou-El Alamin
Ultra-performance liquid chromatography coupled to electrospray ionization-tandem mass spectrometric method for simultaneous determination of acemetacin in presence of its metabolite indomethacin and degradation products
European Journal of Chemistry 7(2), 213, 2016
DOI: 10.5155/eurjchem.7.2.213-216.1434
[2]. Mohamed A. Abdelgawad, Asmaa I. Owis, Nada S. Abdelwahab
Design and optimization of a reversed-phase HPLC with diode array detection method for the determination of acemetacin and its toxic impurities using experimental design
Separation Science Plus 1(4), 244, 2018
DOI: 10.1002/sscp.201700045
[3]. Eman M Moaaz, Ezzat M Abdel-Moety, Mamdouh R Rezk, Ahmed S Fayed
Eco-Friendly Chromatographic Methods for Determination of Acemetacin and Indomethacin; Greenness Profile Assessment
Journal of AOAC INTERNATIONAL 104(6), 1485, 2021
DOI: 10.1093/jaoacint/qsab085
[4]. 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
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DOI Link: https://doi.org/10.5155/eurjchem.6.4.422-429.1313
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European Journal of Chemistry 2015, 6(4), 422-429 | doi: https://doi.org/10.5155/eurjchem.6.4.422-429.1313 | Get rights and content
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