Forced degradation study and characterization of main impurities of ibuprofen soft gelatin capsules by LC-MS-QTOF

Autor(es)

Farias, F. F. ^[1] ; Martins, V. A. P. ^[1] ; Doerr, F. A. ^[2] ; Trujillo, L. M. ^[1] ; Pinto, E. ^[2]

Afiliação do(s) autor(es)

^[1] Adolfo Lutz Inst, Nucleus Phys & Chem Testing Med NFQM, Sao Paulo - Brazil

^[2] Univ Sao Paulo, Sch Pharmaceut Sci, Dept Clin & Toxicol Anal, BR-05508900 Sao Paulo, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Pharmazie; v. 76, n. 4, p. 138-144, APR 2021.
• Citações Web of Science: 0

Resumo

Ibuprofen soft gelatin capsules were subjected to degradation under acidic, basic, oxidation, photolytic, thermal, humidity, and metal ions conditions. To analyse the degradation products, a reversed-phase liquid chromatography (RP-LC) indicative stability method was successfully developed. Chromatographic separation was achieved using a Poroshell HPH-C18 150 x 4.6 mm, 4 mu m, column at 25 degrees C, with a mobile phase constituted by 0.1% phosphoric acid and acetonitrile in gradient at a flow rate of 1.0 mL.min(-1), using ultraviolet detection at 220 nm and injection volume of 20 mu L. In total, eight unknown impurities were found. The peaks RRt 0.49, RRt 0.75, and RRt 0.95 were above 0.17%, corresponding to the identification threshold. Those were identified and characterized by LC-MS-QTOF, with the same chromatographic conditions, except for the exchange of 0.1% phosphoric acid for 0.1% formic acid. The impurities originated from the interaction of ibuprofen with excipients: esterification with PEG, with sorbitol/sorbitan, and with glycerol by-products, which has not yet been reported in the literature. The developed method can be used in several pharmaceutical areas as quality control of impurities, studies of forced degradation, and for the development of future formulations. (AU)

• Processo FAPESP: 12/05198-0 - Estratégias analíticas para a triagem e determinação do triptofano e seus metabólitos em cultura de células de glioma humano
• Beneficiário: Ernani Pinto Junior
• Modalidade de apoio: Auxílio à Pesquisa - Regular
• Processo FAPESP: 20/16211-4 - Estudo de degradação forçada e caracterização das principais impurezas das cápsulas líquidas de ibuprofeno por LC-MS-QTOF
• Beneficiário: Ernani Pinto Junior
• Modalidade de apoio: Auxílio à Pesquisa - Publicações científicas - Artigo