A rapid method for simultaneous determination of two statin drugs based on zwitterionic chromatography (ZIC) had been developed and validated. The development method included examining the effects of chromatographic conditions, including the percentage of organic modifier, pH values, ionic strength of the acetate buffer, and the predominant retention mechanism's experimental determination. Separation developed by two zwitterionic stationary phases (100 mm × 4.6 mm I.D., 3.5µ). The influence of various spacer lengths was being used as an examination tool on atorvastatin and rosuvastatin retention behaviours. Two zwitterionic stationary phases and a mobile phase consisting of acetonitrile and acetate (pH = 4.75, 40 mM) in a ratio of 80:20 V/V were used to achieve optimum chromatographic conditions. The methods had been validated for linearity, accuracy, and precision. This validation shows that the ZIC-HILIC methods proposed were sufficient for quantification analysis of atorvastatin and rosuvastatin. Quantifications were achieved with U.V. detection at 240 nm over the concentration range of 0.1–7.0 μg mL-1 for atorvastatin and rosuvastatin, respectively.

Ali Mohammed Mahir Fahad, Ashraf Saad Rasheed and Hameed Hussien Ali