Application of high performance liquid chromatography and capillary electrophoresis for determination of impurity profile of third-generation antihistaminic drugs

• Grant number: 15/11210-1
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2016
• End date: September 30, 2018
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Anil Kumar Singh
• Grantee: Anil Kumar Singh
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Fernando Mauro Lanças ; Maria Ines Rocha Miritello Santoro ; Nájla Mohamad Kassab

Abstract

Allergy is an exaggerated response of the immune system, when individuals with hypersensitivity are exposed to antigens, agents such as fungi, mites, insects, foods, medicines, dust, pet dander, chemicals, among other numerous allergenic substances.It´s foreseen that, in the last few decades, a rapid worldwide growth of people afflicted by allergic reactions, and that fact can be attributed to environmental factors, such as increased exposure to pollutants and increased permanence in closed areas. Specifically, Brazil presents indexes above the worldwide average of allergic people.It is evident that there is still no effective drug for the treatment of allergy. There are drugs that help control allergic reactions. The class of drugs commonly used to treat allergic reactions are antihistamines (H1 antihistamines), also called anti-allergic agents.Antihistamines H1 are classified into three categories, the first generation (cause drowsiness and penetrates Blood Brain Beerier); the second generation (do not cause sedation or drowsiness because hardly penetrates into central nervous system); and, finally, the third generation (an evolution of the second-generation H1 antihistamines with similar activity and do not cause drowsiness).In present research project, our intention is to study impurity profiles of these third-generation antihistamines using modern analytical methods such as high-performance liquid chromatography and capillary electrophoresis. The microemulsion liquid-chromatography (ME-LC) and microemulsion electrokinetic chromatography (MEEKC) methods will be developed, validated and applied in the quality control assay of 09 (nine) antihistamines with amphoteric and/or zwitterionic characteristics. Moreover, the impurity profile of these antihistaminic drugs will be assed in drug formulations available in Brazilian market through hyphenated DAD and/or mass spectrometric detectors.We aspire, through this research project; enlarge scientific and academic knowledge on the proposed objectives. Make quality control laboratory at FCF-USP a core of excellence and reference in research in this area. Expand the capacity for training of highly qualified professionals, so that they may contribute to science, technology and innovation for sustainable growth of State of Sao Paulo. The project aim at generating positive reflexes in the country's growth, strengthen the graduate program in pharmaceutical sciences at University of Sao Paulo, widen collaborations with other research groups outside the State of Sao Paulo and consequently generate resources and professional competence. The present project has a sight to increasing productive capacity and innovation, and contribute to the improvement of public health of the Brazilian population, especially in the State of Sao Paulo, SP. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

DE ALMEIDA LEITE, HEITOR OLIVEIRA; KASSAB, NAJLA MOHAMAD; AURORA PRADO, MARIA SEGUNDA; SINGH, ANIL KUMAR. Stability-indicating methods applied in the separation and characterization of the main degradation product of propafenone. SEPARATION SCIENCE PLUS, v. 1, n. 7, p. 490-497, JUL 2018. (15/11210-1)

DA COSTA, LUCAS MACIEL; DE ALMEIDA LEITE, HEITOR OLIVEIRA; KASSAB, NAJLA MOHAMAD; SINGH, ANIL KUMAR. Green Analytical Methods for the Separation of Seven Antihistamines: Application in Separation of Azelastine and Related Impurities in Nasal Solution. INTERNATIONAL JOURNAL OF ANALYTICAL CHEMISTRY, v. 2019, p. 11-pg., 2019-01-01. (15/11210-1)

DA COSTA, LUCAS MACIEL; DE ALMEIDA LEITE, HEITOR OLIVEIRA; KASSAB, NAJLA MOHAMAD; SINGH, ANIL KUMAR. Green Analytical Methods for the Separation of Seven Antihistamines: Application in Separation of Azelastine and Related Impurities in Nasal Solution. INTERNATIONAL JOURNAL OF ANALYTICAL CHEMISTRY, 2019. (15/11210-1)