Validacija HPLC metode za određivanje sadržaja i onečišćenja u piracetam aktivnoj supstanci

master's thesis

• Title (english): Validation of HPLC method for assay and impurities determination in piracetam active substance
• Author: Blanka Gabrić
• Mentor: Sandra Babić (mentor)
• Committee member: Sandra Babić (predsjednik povjerenstva)
• Committee member: Svjetlana Krištafor (član povjerenstva)
• Committee member: Matija Cvetnić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Chemical Engineering and Technology; Zagreb
• Defense date and country: 2022-09-28, Croatia
• Scientific / art field, discipline and subdiscipline: NATURAL SCIENCES; Chemistry

Abstract

Piracetam je ljekovita tvar iz skupine nootropika. Nootropici su lijekovi koji podržavaju kognitivne procese: učenje, pamćenje, pažnju i svijest. Na tržištu je prisutan u obliku kapsula Oikamid 400 mg, proizvođač Pliva Hrvatska. Svrha ovog rada je opisati postupak validacije za određivanje sadržaja i onečišćenja u piracetam aktivnoj supstanci. Cijeli validacijski postupak izveden je u laboratorijima Kontrole kvalitete, Pliva Hrvatska prema internim propisima i pod GMP uvjetima. Sva provedena ispitivanja u skladu su s važećim regulatornim smjernicama, uključujući ICH smjernice i Europsku farmakopeju (Ph. Eur). Kroz eksperimentalni dio rada validirana je Ph. Eur. metoda za određivanje sadržaja i onečišćenja u piracetamu kako bi se osiguralo da će predloženi postupak biti uspješno implementiran u laboratorijima Kontrole kvalitete. HPLC tehnikom s DAD (engl. Diode Array Detector) detektorom ispitani su sljedeći validacijski parametri: selektivnost (sadržaj, onečišćenja), osjetljivost (onečišćenja), preciznost (sadržaj, onečišćenja), stabilnost standardnih otopina i otopina uzoraka (sadržaj, onečišćenja), točnost (onečišćenja), linearnost (sadržaj, onečišćenja) i robusnost (sadržaj, onečišćenja).

Abstract (english)

Piracetam is an active pharmaceutical substance from the group of nootropics. Nootropics are drugs that support cognitive processes: learning, memory, attention and awareness. It is present on the market in the form of Oikamid 400 mg capsules, manufactured by Pliva Hrvatska. The aim of this work is to describe the validation procedure for assay and impurities determination in piracetam active substance. The entire validation procedure was performed in the Quality Control laboratories, Pliva Hrvatska according to internal regulations and under GMP conditions. All tests performed are in accordance with current regulatory guidelines, including ICH guidelines and the European Pharmacopoeia (Ph. Eur). Through the experimental part of the thesis, the Ph. Eur. procedure for assay and impurities determination was validated to ensure that the proposed analytical method will be succesfully implemented in Qualiy Control laboratories. The following validation parameters were tested using the HPLC technique with Diode Array Detector, DAD: selectivity (assay, impurities), sensitivity (impurities), precision (assay, impurities), stability of standard and sample solution (assay, impurities), accuracy (impurities), linearity (assay, impurities) and robustness (assay, impurities).

• Keywords: Piracetam; HPLC; validacija; onečišćenje; sadržaj
• Keywords (english): Piracetam active pharmaceutical substance; HPLC; validation; impurities; assay
• Language: croatian
• URN:NBN: urn:nbn:hr:149:924080
• Study programme: Title: Materials Science and 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: Closed access
• Created on: 2023-03-28 09:12:19