Analysis of procainamide from pharmaceutical preparation and plasma by green HPLC

In drug analysis, using non-hazardous solvents instead of these solvents harmful to the human and environment is a greening strategy to protect analyst and environmental health and minimize produced toxic waste budged. Procainamide (PA) is an antiarrhythmic drug requiring TDM due to its narrow therapeutic window and serious side effects. The aim of thesis is to develop green HPLC methods to be used in drug quality control and TDM analysis for PA as an example to this class drugs. Thus, human friendly ethanol was selected as organic solvent in mobile phase, and the green HPLC methods for the analysis of PA in pharmaceutical preparation and in plasma was developed and validated. PA was eluted from Nucleodur 100-5 C8 ec (5 µm, 150 x 4,6 mm) column by a mobile phase containing ethanol and 50 mM NaH2PO4 buffer (5:95, h/h). Mobile phase flow rate was 1,0 ml dk-1, column temperature was 35 °C and the wavelength at PDA detector was 279 nm. Retention time for PA was 5.0 min and was 7.7 min for IS paracetamol. Green HPLC method for PA analysis in pharmaceuticals was linear in the range of 1-50 µg ml-1. The highest RSD and mean recovery values for the method were 0,88% and 98,89%, respectively. In the analysis of plasma PA, sample preparation was only a smooth protein precipitation by ethanol. Thus, sample preparation step was also become green. LOD of the method was 0,3 µg ml-1 and LOQ was 0,8 µg ml-1. The therapeutic plasma concentration for PA has been reported in the range of 4–12 μg ml−1. Green bioanalytical method developed in this study was linear in the range of 1,5-30 µg ml-1 PA concentration, and its BBS value was 3,3% and the mean recovery was 97,27%. As a result, the green HPLC methods developed and validated in this thesis were selective, accurate, precise, reproducible, trustable and have the quality and ability for the application in pharmaceutical and TDM analysis of PA.