Bilastine: Quantitative Determination by LC with Fluorescence Detection and Structural Elucidation of the Degradation Products Using HRMS.
J AOAC Int
; 103(6): 1451-1460, 2020 Nov 01.
Article
em En
| MEDLINE
| ID: mdl-33247742
ABSTRACT
BACKGROUND:
A liquid chromatography (LC) stability-indicating method was developed and validated for the quantitative determination of bilastine in coated tablets.OBJECTIVE:
The procedure was validated for specificity, linearity, robustness, precision, and accuracy. Plackett-Burmann experimental design was used to determine the robustness of the method.METHOD:
Chromatographic separation was performed on a Shim-pack® RP-18 column with fluorescence detection. The degradation products formed under oxidative conditions were isolated and identified using high-resolution mass spectrometry (HRMS). In silico prediction of degradation products and in silico toxicity studies were also performed.RESULTS:
The LC method presented good recovery and precision (intraday and interday), the response was linear in a range of 0.20 to 0.70 µg mL-1, and the results demonstrated the robustness of the analytical method under the evaluated conditions.CONCLUSIONS:
The degradation products were identified as benzimidazole (DP1) and amine N-oxide of bilastine (DP2). The results for the toxicity studies demonstrated the high mutagenic potential of DP1 and hepatotoxicity and hERG I inhibitor effects of DP2. HIGHLIGHTS Bilastine degradation products were identified as benzimidazole and amine N-oxide using HRMS.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piperidinas
/
Benzimidazóis
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article