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Updated: Nov 28, 2025
Quantitative and Qualitative Method for Sphingomyelin by LC-MS Using Two Stable Isotopically Labeled Sphingomyelin Species
Published on: May 7, 2018
Bilastine: Quantitative Determination by LC with Fluorescence Detection and Structural Elucidation of the Degradation
Paola Ribeiro Motta1,2, Douglas Dos Santos Porto1, Paulo Roberto Rodrigues Martini1
1Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade, Curso de Farmácia, Universidade Federal do Pampa (UNIPAMPA-Campus Uruguaiana-RS), BR 472-Km 585, CEP 97500-970 Uruguaiana (RS), Brazil.
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.
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