Razvoj i validacija metode za određivanje metadona i metoklopramida u tabletama primjenom ramanove spektroskopije

master's thesis

• Title (english): Development and validation of a method for determining of methadone and metoclopramide in tablets using raman spectroscopy
• Author: Ivan Pižir
• Mentor: Jasna Jablan (mentor)
• Committee member: Jasna Jablan (predsjednik povjerenstva)
• Committee member: Mario Jug (član povjerenstva)
• Committee member: Ivana Bačić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of analytical chemistry); Zagreb
• Defense date and country: 2021-04-30, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Metadon je sintetski opioid koji se danas primarno koristi kao supstitucijska terapija u liječenju opioidne ovisnosti te se sve više istražuje, ali i koristi u liječenju kronične boli. Metoklopramid je primarno indiciran u odraslih za prevenciju i simptomatsko liječenje mučnine i povraćanja induciranih radioterapijom i kemoterapijom. Problem je što metoklopramid čini gotovo polovinu potrošnje lijekova za funkcionalne GIT poremećaje, a indiciran je samo kao dodatna terapija. Svrha ovog diplomskog rada bila je razviti i validirati brzu i jednostavnu metodu za određivanje metadona i metoklopramida u tabletama primjenom disperzivne Ramanove spektroskopije, a zatim ispitati razvijenu metodu u određivanju udjela metadona i metoklopramida u komercijalno dostupnim tabletama. Preliminarnim ispitivanjima odabran je laser 785 nm i laktoza kao najbolje punilo. Kod validacije analitičke metode ispitivani su parametri: linearnost, homogenost, preciznost (ponovljivost i srednja preciznost), točnost te granica određivanja i dokazivanja. Rezultati provedenih validacijskih mjerenja za sve parametre većinom su se nalazili unutar postavljenih granica, a svako odstupanje se može objasniti pogreškom analitičara prilikom pripreme uzorka. Primjenom validirane metode na realne uzorke, dobivene su vrijednosti metadona i metoklopramida u uzorcima tableta te su uspoređene s deklariranim. U daljnjim istraživanjima primjenjivati će se kemometrijski pristup analizi podataka zbog bolje kvantifikacije djelatnih tvari u uzorcima.

Abstract (english)

Methadone is a synthetic opioid used primarily as replacement therapy in the treatment of opioid dependence and is increasingly being researched, but it is also used in the treatment of chronic pain. Metoclopramide is primarily indicated in adults for the prevention and symptomatic treatment of nausea and vomiting induced by radiation and chemotherapy. Problematically, metoclopramide accounts for almost half of drug use in functional GIT disorders, although it is only indicated as adjunctive therapy. The aim of this work was to develop and validate a fast and simple method for the determination of methadone and metoclopramide in tablets using dispersive Raman spectroscopy, and then to investigate the developed method in the determination of the proportion of methadone and metoclopramide in tablets. In preliminary experiments, a 785 nm laser and lactose were selected as the best filler. In the validation of the analytical method, the following parameters were examined: linearity, homogeneity, precision (repeatability and intermediate precision), accuracy and limits of detection and quantification. The results of the validation measurements performed for all parameters, are mostly within the specified limits, with deviations due to errors made by analyst during sample preparation. Using a validated method on real samples, the values of the content of methadone and metoclopramide in tablet samples were determined and compared with the declared content. In further studies, a chemometric approach to data analysis will be applied to achieve better quantification of the active ingredients in the samples.

• Keywords: Ramanova spektroskopija; metadon; metoklopramid; validacija analitičke metode
• Keywords (english): Raman spectroscopy; methadone; metoclopramide; validation
• Language: croatian
• URN:NBN: urn:nbn:hr:163:999290
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2021-11-16 15:34:06