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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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.


Keywords


HPLC; Impurities; Acemetacin; PLS regression model; Degradation products; Stability indicating methods

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DOI: 10.5155/eurjchem.6.4.422-429.1313

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How to cite


Kessiba, A.; Hegazy, M.; Abdelkawy, M.; El Gendy, A. Eur. J. Chem. 2015, 6(4), 422-429. doi:10.5155/eurjchem.6.4.422-429.1313
Kessiba, A.; Hegazy, M.; Abdelkawy, M.; El Gendy, A. Stability-indicating HPLC and PLS chemometric methods for the determination of acemetacin in presence of its degradation products and impurities. Eur. J. Chem. 2015, 6(4), 422-429. doi:10.5155/eurjchem.6.4.422-429.1313
Kessiba, A., Hegazy, M., Abdelkawy, M., & El Gendy, A. (2015). Stability-indicating HPLC and PLS chemometric methods for the determination of acemetacin in presence of its degradation products and impurities. European Journal of Chemistry, 6(4), 422-429. doi:10.5155/eurjchem.6.4.422-429.1313
Kessiba, Amira, Maha Abdel Monen Hegazy, Mohamed Mohamed Abdelkawy, & Ahmed Emad El Gendy. "Stability-indicating HPLC and PLS chemometric methods for the determination of acemetacin in presence of its degradation products and impurities." European Journal of Chemistry [Online], 6.4 (2015): 422-429. Web. 29 May. 2020
Kessiba, Amira, Hegazy, Maha, Abdelkawy, Mohamed, AND El Gendy, Ahmed. "Stability-indicating HPLC and PLS chemometric methods for the determination of acemetacin in presence of its degradation products and impurities" European Journal of Chemistry [Online], Volume 6 Number 4 (31 December 2015)

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DOI Link: https://doi.org/10.5155/eurjchem.6.4.422-429.1313

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