Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets

Our main target and concept was to develop a method for the determination of most prescribed antilipemic drug, atorvastatin, together with its related substances, single sample preparation during chromatographic run, in shortest possible period time, lowest mobile phase consumption. A new rapid, simple atorvastatin specified impurities developed, using different columns. With this powerful core–shell, or superficially porous silica-based column, satisfactory results targeted parameters, such as critical peak resolution, run time length, column backpressure, were achieved. The analysis is performed within duration less than 15 min, which about six times shorter official European Pharmacopoeia method. chromatogram performances suggests that limit quantification (LOQ) can be 7 lower, detection (LOD) 20 an injection volume only 2 µl. This confirmed by validation accordance International Conference on Harmonization (ICH) guideline analytical procedures Q2(R1), where selectivity, linearity, accuracy, precision, quantification, tested confirmed.