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International Journal of Drug Development and Research

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Identification of degradation products of fensipiride hydrichloride in stress degradation media

17th Edition of International Conference and Exhibition on Pharmaceutics and Novel Drug Delivery Systems
October 04-06, 2018 Moscow, Russia

Ioana Caba, Marius Niculaua, Lumini??a Agoroaei and Bogdan Cioroiu

Grigore T Popa University of Medicine and Pharmacy, Romania Romanian Academy-Iasi Branch, Romania

Posters & Accepted Abstracts: Int J Drug Dev & Res

Abstract:

Fenspiride hydrochloride is used on chronic inflammatory diseases. Most used formulations are liquid oral solutions. Fenspiride hydrochloride (FNS) enables a series of degradation products along with fenspiride N-oxide (FNO) and 1-phenylethyl- 4-hydroxy-4-aminomethyl piperidine hydrochloride (PHAP). The method of determination includes a mobile phase consisted in a quaternary mixture formed of solution pH 4.5, acetonitrile, methanol and solution of pH 2.9. Workflow was 1.5 mL min-1 and the elution was a double gradient in organic solvent and from solution with pH 4.5 to 2.9. Linearity interval ranged between 0.5 μg mL-1 to 2 μg mL-1 and correlation coefficients are minimum 0.999. Recovery factors were between 100.47% and 103.17% and the limits of qualification were between 0.19 and 0.332 μg/ ml. intra-day precision was of maximum 4.08% for FNS and 2.65% for PHAP. This double gradient of mobile phase produced a good specificity in relation with the degradation products of fenspiride hydrochloride and other constituents of the liquid oral solution. Forced degradation studies revealed another related substances and degradation studies confirmed in mass balance analysis. Degradation products were confirmed in acidic, basic and oxidation media. A full factorial design was used for the optimization of model. Previous mentioned parameters were considered as started conditions. The design had a number of 2 factors, 4 runs and 1 block. The factors were coded as -1 and +1. First factor was associated with the variation of pH. The second factor was acetonitrile gradient (ACN) in the mobile phase. As pH, acetonitrile modification produced a important modification in terms of resolution and separation efficiency. The full factorial design used a multi-linear regression model and evaluated the final response as a function of constant of experimental response and the estimated effects of the factors. Most important parameters which affected the method specificity were pH, temperature and organic components.

Biography :

Dr Ioana Caba has completed his PhD in Toxicology by Faculty of Pharmacy, University of Medicine and Pharmacy GRIGORE T POPA, Iasi, Romania. During and after the PhD studies, she has attended a transnational internship, at Faculty of Chemistry, Sevillia, Spain and at Faculty of Pharmacy, University of Porto, Portugal. She has worked as Assistant professor of Toxicology at University of Medicine and Pharmacy GRIGORE T POPA, Iasi, Romania and she has published more than 10 papers in journals.

E-mail: [email protected]