Quality control and drug dissolution studies of pharmaceutical preparations containing cerivastatin sodium by means of RP-HPLC

A novel, rapid, sensitive, accurate, and simple isocratic HPLC assay was developed to determine cerivastatin in pharmaceutical dosage forms and human serum. The proposed method was conducted using a reverse phase technique, UV monitoring at 232 nm, and losartan potassium as an internal standard. The detector response was linear in the range of 25-10000 ng/mL. This compound is well separated with a Waters C-18 column (150 x 4.6 mm; 5 mum particle size) by using a mobile phase consisting of a mixture of acetonitrile:0.01 M KH2PO4 adjusted to pH 3.1 with H3Po4 (35:65 v/v), at a flow rate of 1.0 mL/min. The limit of detection and the limit of quantitation of the procedure were 0.62 ng/mL and 2.07 ng/mL for cerivastatin, respectively. The retention time was 6.90 min for cerivastatin and 8.78 min for internal standard. No interferences were observed from tablet additives and the applicability of the method was examined by analyzing tablets containing cerivastatin. This method was also applied, without any interference froth the excipients, for the determination of cerivastatin in drug dissolution studies. The proposed method was successfully applied to the analysis of cerivastatin in human serum.