Development of ultra-high performance liquid chromatographic method for determination of potentially genotoxic impurities in the fosamprenavir

Fosamprenavir je protuvirusni lijek koji se koristi za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa 1. Prilikom proizvodnje lijekova mogu nastati nečistoće koje je potrebno detaljno ispitati kako ne bi došlo do ugrožavanja zdravlja pacijenta. U ovom diplomskom radu razvijena je metoda tekućinske kromatografije ultravisoke djelotvornosti za analizu potencijalno genotoksičnih onečišćenja u lijeku Fosamprenavir, prema načelima kvalitete ugrađene u dizajn, primjenom računalnog programa DryLab®. Razvijena je metoda čiji eksperimentalni uvjeti iznose: pH-vrijednost mobilne faze 4,00; temperatura kolone 60 °C i vrijeme gradijentnog eluiranja 3 minute. Pomoću razvijene metode moguće je odrediti koncentraciju genotoksičnih onečišćenja u vrlo niskim koncentracijama od 1 mg/L.Fosamprenavir is an antiviral drug that is used to treat patients infected with the human immunodeficiency virus type 1. During the production of drugs, impurities may arise that must be examined in detail in order not to endanger the patient's health. In this thesis, an ultrahigh-performance liquid chromatography method was developed for the analysis of potentially genotoxic contaminants in the drug Fosamprenavir, according to the principles of quality by design, using the computer program DryLab®. A method was developed whose experimental conditions were: pH-value of the mobile phase 4.00; column temperature 60 °C and gradient elution time 3 minutes. Using the developed method, it is possible to determine the concentration of genotoxic impurities in very low concentrations of 1 mg/L