Razvoj i validacija instumentalne metode kapilarne elektroforeze u farmaceutskoj industriji

master's thesis

• Title (english): Method development and validation of an instrumental method of capillary electrophoresis in the pharmaceutical industry
• Author: Paulina Mikulić
• Mentor: Katarina Berković (mentor)
• Granter: University of Zagreb; Faculty of Food Technology and Biotechnology; (Department of Chemistry and Biochemistry); (Laboratory for Physical Chemistry and Corrosion); Zagreb
• Defense date and country: 2008-05-13, Croatia
• Scientific / art field, discipline and subdiscipline: BIOTECHNICAL SCIENCES; Biotechnology

Abstract

Razvijena je instrumentalna metoda kapilarne elektroforeze (CE) za kvantifikaciju estramustin fosfata natrija u uzorku „Estracyt“ kapsula nakon pokusa oslobađanja djelatne tvari. Pokus oslobađanja djelatne tvari je standardizirana metoda za određivanje količine oslobođene djelatne tvari iz lijeka u uvjetima koji simuliraju in vivo uvjete. Pri razvoju metode optimirani su sljedeći parametri metode: vrsta, pH vrijednost i koncentracija radnog pufera, udio organskog modifikatora u radnom puferu, radni napon, uvjeti hidrodinamskog injektiranja i temperatura kapilare. Razvijena metoda je validirana, pri čemu su određeni sljedeći validacijski aspekti: specifičnosti, linearnosti, točnosti i osjetljivosti. Razvijena CE metoda uspoređena je sa službenom metodom za analizu. Rezultati su pokazali da je razvijena i optimirana CE metoda specifična, linearna, precizna, točna i dovoljno osjetljiva za ispitivanu koncentraciju analita.

Abstract (english)

An instrumental method has been developed using capillary electrophoresis (CE) for the quantification of estramustine phosphate sodium in samples of „Estracyt“capsules obtained by dissolution testing. Dissolution testing is a standardised method for determining the rate of drug release from a dosage form in conditions simulating in vivo conditions. Method development involved the optimisation of the type, pH value and concentration of run buffer, the amount of organic modifier in the run buffer, voltage, conditions of hydrodynamic injection and the temperature of the capillary. The method developed was validated by determining the following aspects of validation: specificity, linearity, accuracy and sensitivity. The developed CE method was compared to the official method used for this analysis. The method developed and optimised proved to be specific, linear, accurate and sensitive enough for the concentration of analyte being determined in this analysis.

• Keywords: razvoj metode; analitički parametri; validacijski aspekti; kapilarna elektroforeza; estramustin fosfat natrij
• Keywords (english): method development; analytical parameters; validation aspects; capillary electrophoresis; estramustine phosphate sodium
• Language: croatian
• URN:NBN: urn:nbn:hr:159:417818
• Study programme: Title: Biotechnology; specializations in: Biochemical Engineering; Course: Biochemical Engineering; Study programme type: university; Study level: graduate; Academic / professional title: diplomirani inženjer biotehnologije; smjer biokemijsko inženjerstvo (diplomirani inženjer biotehnologije; smjer biokemijsko inženjerstvo)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Access restricted to students and staff of home institution
• Created on: 2017-09-05 09:36:05