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Chromatographic methods development, validation and degradation characterization of the antithyroid drug Carbimazole.
Biomed Chromatogr 2019; 33(4):e4472BC

Abstract

The current paper reports the development and validation of stability-indicating HPLC and HPTLC methods for the separation and quantification of main impurity and degradation product of Carbimazole. The structures of the degradation products formed under stress degradation conditions, including hydrolytic and oxidative, photolytic and thermal conditions, were characterized and confirmed by MS and IR analyses. Based on the characterization data, the obtained degradation product from hydrolytic conditions was found to be methimazole-impurity A of Carbimazole as reported by the British Pharmacopeia and the European Pharmacopeia. A stability-indicating HPLC method was carried out using a Zorbax Eclipse Plus CN column (150 × 4.6 mm i.d, 5 μm particle size) and a mobile phase composed of acetonitrile-0.05 m KH2 PO4 (20: 80, v/v) in isocratic elution, at a flow rate of 1 mL/min. The method was proved to be sensitive for the determination down to 0.5% of Carbimazole impurity A. Additionally, a stability-indicating chromatographic HPTLC method was achieved using cyclohexane-ethanol (9:1, v/v) as a developing system on HPTLC plates F254 with UV detection at 225 nm. The proposed HPLC and HPTLC methods were successfully applied to Carbimazole® tablets with mean percentage recoveries of 100.12 and 99.73%, respectively.

Authors+Show Affiliations

Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt. Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Nahda University, Beni-Suef, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30577074

Citation

Abdelrahman, Maha M.. "Chromatographic Methods Development, Validation and Degradation Characterization of the Antithyroid Drug Carbimazole." Biomedical Chromatography : BMC, vol. 33, no. 4, 2019, pp. e4472.
Abdelrahman MM. Chromatographic methods development, validation and degradation characterization of the antithyroid drug Carbimazole. Biomed Chromatogr. 2019;33(4):e4472.
Abdelrahman, M. M. (2019). Chromatographic methods development, validation and degradation characterization of the antithyroid drug Carbimazole. Biomedical Chromatography : BMC, 33(4), pp. e4472. doi:10.1002/bmc.4472.
Abdelrahman MM. Chromatographic Methods Development, Validation and Degradation Characterization of the Antithyroid Drug Carbimazole. Biomed Chromatogr. 2019;33(4):e4472. PubMed PMID: 30577074.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Chromatographic methods development, validation and degradation characterization of the antithyroid drug Carbimazole. A1 - Abdelrahman,Maha M, Y1 - 2019/01/30/ PY - 2018/10/21/received PY - 2018/12/03/revised PY - 2018/12/14/accepted PY - 2018/12/24/pubmed PY - 2019/4/9/medline PY - 2018/12/22/entrez KW - Carbimazole KW - HPLC KW - HPTLC KW - SIAM KW - methimazole KW - oxidative degradation SP - e4472 EP - e4472 JF - Biomedical chromatography : BMC JO - Biomed. Chromatogr. VL - 33 IS - 4 N2 - The current paper reports the development and validation of stability-indicating HPLC and HPTLC methods for the separation and quantification of main impurity and degradation product of Carbimazole. The structures of the degradation products formed under stress degradation conditions, including hydrolytic and oxidative, photolytic and thermal conditions, were characterized and confirmed by MS and IR analyses. Based on the characterization data, the obtained degradation product from hydrolytic conditions was found to be methimazole-impurity A of Carbimazole as reported by the British Pharmacopeia and the European Pharmacopeia. A stability-indicating HPLC method was carried out using a Zorbax Eclipse Plus CN column (150 × 4.6 mm i.d, 5 μm particle size) and a mobile phase composed of acetonitrile-0.05 m KH2 PO4 (20: 80, v/v) in isocratic elution, at a flow rate of 1 mL/min. The method was proved to be sensitive for the determination down to 0.5% of Carbimazole impurity A. Additionally, a stability-indicating chromatographic HPTLC method was achieved using cyclohexane-ethanol (9:1, v/v) as a developing system on HPTLC plates F254 with UV detection at 225 nm. The proposed HPLC and HPTLC methods were successfully applied to Carbimazole® tablets with mean percentage recoveries of 100.12 and 99.73%, respectively. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/30577074/Chromatographic_methods_development_validation_and_degradation_characterization_of_the_antithyroid_drug_Carbimazole_ L2 - https://doi.org/10.1002/bmc.4472 DB - PRIME DP - Unbound Medicine ER -