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Atorvastatin analysis by fully validatedHPLC assay in human plasma

Reem Saleh Alswayeh, Muhammad M.Hammami

Asimple, sensitive high-performance liquid chromatography (HPLC) assay for atorvastatin measurement in human plasma was fully validated, and atorvastatin stability was studied. After one-step extraction of 1ml plasma with 5.0ml of ethyl acetate and reconstitution in mobile phase, glipizide (internal standard, IS) and atorvastatin eluted at 4.6 and 8.7 minutes, respectively, on anAtlantis C18, 5msteel at roomtemperature (RT), and were detected using a Water 2690 dual absorbance detector set at 247nm. The mobile phase, 0.05 M dibasic sodium phosphate buffer (pH = 4.0) and acetonitrile (50:50, v:v), was delivered at 1.0ml/min. Calibration curves were linear in the range 0.02-1.0g/ml, and intra- and inter-run coefficients of variation were  12 % and 13.1 %, respectively. Extraction recovery and intra- and inter-run biaswere  81%(mean 91%), 14%, and  10%, respectively. Atorvastatinwas stable in plasma for 24 hours atRT ( 95%), 6 weeks at -20C ( 85%), and after 3 cycles of freeze at -20C and thaw at RT ( 90%). In extracted samples, atorvastain was stable for 24 hours at RT ( 96%) and 48 hours at -20C ( 96%). Atorvastatin (1 mg/ml) in water was stable for 48 hours at RT (88%) and 6 weeks at -20C (112%).