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master's thesis
Razvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu
Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry, 2016. urn:nbn:hr:163:517152
Brzović, Ana
University of Zagreb
Faculty of Pharmacy and Biochemistry
Department of pharmaceutical analysis

Institutional repository: Repository of Faculty of Pharmacy and Biochemistry University of Zagreb

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Brzović, A. (2016). Razvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu (Master's thesis). Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry. Retrieved from https://urn.nsk.hr/urn:nbn:hr:163:517152

Brzović, Ana. "Razvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2016. https://urn.nsk.hr/urn:nbn:hr:163:517152

Brzović, Ana. "Razvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2016. https://urn.nsk.hr/urn:nbn:hr:163:517152

Brzović, A. (2016). 'Razvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu', Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, accessed 22 November 2024, https://urn.nsk.hr/urn:nbn:hr:163:517152

Brzović A. Razvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu [Master's thesis]. Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry; 2016 [cited 2024 November 22] Available at: https://urn.nsk.hr/urn:nbn:hr:163:517152

A. Brzović, "Razvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu", Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, 2016. Available at: https://urn.nsk.hr/urn:nbn:hr:163:517152

Metadata
TitleRazvoj i validacija metode za određivanje elementarnih onečišćenja u eritromicinu
Title (english)Development and validation of analytical method for determination of elemental impurities in erythromycin
AuthorAna Brzović
MentorBiljana Nigović (mentor)
Committee memberBiljana Nigović (predsjednik povjerenstva)
Committee memberAna Mornar Turk (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Pharmacy and Biochemistry
(Department of pharmaceutical analysis)
Zagreb
Defense date and country2016-09-30, Croatia
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Pharmacy
Pharmacy
Abstract
Eritromicin je antibiotik u klasi makrolida, strukturno sličnih spojeva koje karakterizira makrociklični prsten. Izoliran je 1952. godine iz Streptomyces erythreus. U ovom radu, razvijena je i validirana brza i učinkovita metoda s kojom se mogu odrediti, u jednom snimanju, sva elementarna onečišćenja propisana ICH Q3D smjernicom u eritromicinu koristeći masenu spektroskopiju s induktivno spregnutom plazmom (ICP-MS). Ispitivanje topljivosti eritromicina pokazalo je da se 100 mg eritromicina izvrsno otapa u 1 mL H2O2 i 1 mL HCl. Kod validacije analitičke metode ispitivani su parametri: linearnost, točnost, granica određivanja, preciznost i ponovljivosti. Rezultati provedenih validacijskih mjerenja za sve parametre nalazili su se unutar unaprijed postavljenih granica pojedinog parametra. Time se pokazalo da je analitička metoda stabilitetno indikativna i prikladna za određivanje onečišćenja u eritromicinu u propisanim uvjetima. Metoda je pokazala da ispitivani uzorak eritromicina ne sadrži elementarna onečišćenja, osim vanadija u koncentraciji manjoj od specifikacije prema ICH te samog limita kvantifikacije, što znači da je uzorak u skladu s propisanim zahtjevima.
Abstract (english)
Erythromycin is an antibiotic belonging to the macrolide class, structurally similar compounds which are characterized by a macrocyclic ring. It was isolated from Streptomyces erythreus in 1952.In this paper an effective method was developed and validated with which it is possible to determine all elementary impurities proposed by ICH Q3D guideline in erythromycin using inductively coupled plasma mass spectrometry (ICP-MS) in a single screening. Solubility testing had shown that 100 mg of erythromycin is excellently soluble in 1 mL of H2O2 i 1 mL of HCL.Following parameters were tested for method validation: linearity, accuracy, limit of quantification, precision and repeatability. Results of the conducted measuring for all parameters were found within boundaries set in advance for each parameter. That has shown that the analytical method is indicative of stability and appropriate for determining impurities in erythromycin within proposed conditions. Method has shown that the tested erythromycin does not contain elementary impurities except for vanadium in a concentration smaller than ICH specification and the limit of quantification meaning that the sample is in accordance with regulatory requirements.
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:163:517152
Study programmeTitle: Pharmacy
Study programme type: university
Study level: integrated undergraduate and graduate
Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
Type of resourceText
File originBorn digital
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2016-12-02 15:58:24