Development and validation of high performance liquid chromatography method for Atorvastatin calcium in pharmaceutical dosage forms
M Diril, G YÄ±ldÄ±z TÃ¼rkyÄ±lmaz and H Y Karasulu
Ege University, Turkey
: J Pharm Drug Deliv Res
Atorvastatin calcium (AtrCa) is a BCS class 2 classification group and displays low resolution with high permeability. AtrCa has almost 14% bioavability absolutely. The aim of this study is to develop and validate an analytical method for oral delivery of AtrCa in pharmaceutical dosage form. The HPLC system consisted of a gradient pump, thermo stable column department and a UV detector supplied by Agilent 1100. The column was a C18 column (5 Î¼m, 150x4,6 mm) (ACE). All UV-Vis spectrums were monitored between 200-400 nm and quantification was performed at 238 nm. The injection volume was 20Î¼L and the retention time of AtrCa was about 7.1 min. The mobile phase was mixture of acetonitrile and 0.1 M sodium di-hydrogen phosphate (55:45) (v/v) and adjusted to pH 3 with trifluoroacetic acid (1 mL) pumped at 1 mL/min. The HPLC method was validated partially with respect to linearity, limit of detection (LOD) and quantitation (LOQ), precision and accuracy. The linearity between peak area and concentration was analyzed using three calibration curves obtained in the different days with standard solutions of AtrCa at 11 different concentrations ranging from 0.065 to 20 ppm for AtrCa. Data indicate that AtrCa peak area is linear over concentration range of 0.065-20 ppm. The R2 for regression line is 0.999 with slope of 61.428 and y+ intercept of 15.33. LOD was found 0.429 Î¼g /mL and LOQ was found 1.30 Î¼g/mL. In conclusion, an efficient high performance liquid chromatographic method was developed and validated method described is suitable for oral delivery of AtrCa.