Content of the vitamin D in pharmaceutical formulations

V diplomskem delu smo določali koncentracije vitamina D3 (holekalciferol) in D2 (ergokalciferol) ter provitamina D3 (7-dehidroholesterol) in D2 (ergosterol) v prehranskih dopolnilih in zdravilih. Za analizo le-teh smo uporabili metodo tekočinske kromatografije v kombinaciji z masno spektrometrijo (LC-MS/MS), ki omogoča identifikacijo in kvantifikacijo teh komponent. Analizna metoda je bila validirana, saj je le tako lahko uporabna za različne vzorce. Pri validaciji metode smo preverjali natančnost, specifičnost, linearnost, mejo zaznavnosti, mejo določljivosti, točnost, robustnost, selektivnost, ponovljivost ter stabilnost in metoda ustreza vsem zahtevam za uporabo. Analizirani vzorci so bili izbrani glede na vsebnost vitamina D v različnih farmacevtskih oblikah. Glede na pripravljeno analizno metodo se je izkazalo, da v večini, predpisana vsebnost vitamina D ustreza le komponenti vitamin D3. V nekaterih pa smo zaznali še vitamin D2 in provitamin D3, medtem ko provitamin D2 v izbranih vzorcih ni bil zaznan. Prav tako večina analiziranih pripravkov ustreza navedbam proizvajalca.In the thesis, we were determining the concentrations of vitamin D3 (cholecalciferol), D2 (ergocalciferol) and provitamin D3 (7-dehydrocholesterol), D2 (ergosterol) in dietary supplements and medical compounds. For their analysis, we used the method of liquid chromatography in combination with mass spectrometry (LC-MS/MS), which allows the identification and quantification of these components. The method of analysis was validated as it can be used for different samples. In the validation process, we checked the accuracy, specificity, linearity, limit of detectability, limit of determination, veracity, robustness, selectivity, repeatability and stability in accordance with all requirements for use. The analysed samples were selected according to the content of vitamin D in various pharmaceutical forms. In line with the prepared method of analysis, it was observed that most of the prescribed vitamin D content only relates to the D3 component. In some cases, vitamin D2 and provitamin D3 were also observed, while provitamin D2 was not detected in selected samples. In addition, most of the analysed compounds correspond to the manufacturers report