Stability study of selected pharmaceutical formulations

master's thesis

• Title (croatian): Studija stabilnosti izabranih farmaceutskih formulacija
• Author: Borna Ferčec
• Mentor: Dragana Mutavdžić Pavlović (mentor)
• Committee member: Dragana Mutavdžić Pavlović (predsjednik povjerenstva)
• Committee member: Danijela Ašperger (član povjerenstva)
• Committee member: Marijana Hranjec (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2016-07-12, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry; Analytic Chemistry

Abstract

An optimized reversed phase HPLC method, for the stability study of formulations containing prostaglandin E1 and papaverine HCl as main components, was developed. Stability study will be performed at seven time points: t0 (starting point), and then after one, two, three, four, five, and finally, six months. Chromatographic separations were achieved on an Alltima C18 5μ column (250 mm x 4.6 mm, 5 μm) and maintained at room temperature using gradient elution. Mobile phase A was a mixture of a 0.02 M phosphate buffer solution (pH 3.0) and acetonitrile (62: 38 v/v). Mobile phase B was a mixture of a 0.02 M phosphate buffer solution (pH 3.0) and acetonitrile (30: 70 v/v). Mobile phases were pumped at a flow rate of 1.2 mL/min. UV detection was performed at 205 nm. The method was validated for specificity, linearity, accuracy, limit of detection, limit of quantification, and precision of the two main peaks. Stability study was performed for t0 (starting point).

Abstract (croatian)

Razvijena je i optimizirana HPLC metoda obrnute faze, za studiju stabilnosti farmaceutskih formulacija koje sadrže prostaglandin E1 i papaverin HCl kao glavne komponente. Studija stabilnosti bit će izvedena kroz sedam vremenskih točaka: t0 (početna vremenska točka), te nakon jedan, dva, tri, četiri, pet, i konačno, šest mjeseci. Kromatografska separacija postignuta je na Alltima C18 5μ koloni (250 mm x 4,6 mm, 5 μm) pri sobnoj temperaturi koristeći gradijentni protok pokretne faze. Pokretna faza A je mješavina 0,02 M fosfatnog pufera (pH 3.0) i acetonitrila (62:38 v/v). Pokretna faza B je mješavina 0,02 M fosfatnog pufera (pH 3.0) i acetonitrila (30:70 v/v). Protok pokretnih faza je 1,2 mL/min. UV detekcija izvedena je pri 205 nm. Metoda je validirana na specifičnost, linearnost, točnost, granice detekcije i kvantifikacije, te preciznost za dva glavna pika. Studija stabilnosti izvedena je za t0 (početna vremenska točka).

• Keywords: pharmaceutical formulations; Prostaglandin E1; Papaverine; HPLC; UV; stability study; method development
• Keywords (croatian): farmaceutske formulacije; Prostaglandin E1; Papaverin; HPLC; UV; studija stabilnosti; razvoj metode
• Language: english
• URN:NBN: urn:nbn:hr:149:473987
• Study programme: Title: Chemical Engineering - Graduate study; Study programme type: university; Study level: graduate; Academic / professional title: magistar/magistra inženjer/inženjerka kemijskog inženjerstva (magistar/magistra inženjer/inženjerka kemijskog inženjerstva)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Public note: Rad je napisan na engleskom jeziku, ali u radu nedostaje stvarni naslov rada na engleskom jeziku koji glasi: Stability study of selected pharmaceutical formulations (preuzeto iz Hrvatske znanstvene bibliografije).
• Created on: 2017-05-31 12:15:40