Determination of pravastatin in tablets by capillary electrophoresis

Abstract

Pravastatin (PRA) is an inhibitor of HMG-CoA reductase enzyme, which is clinically used as a hypolipidemic agent to reduce cholesterol level. A capillary electrophoretic method for the determination of PRA in pharmaceutical tablet formulations is described. PRA and lansoprazole as an internal standard (IS) were well migrated in the background electrolyte of 10 mM borate buffer (pH 8.5) and 10% acetonitrile using a fused silica capillary. The separation was achieved by applying 27.5 kV, detecting at 200 nm and injecting the sample for 0.5 s and with an average migration time (tm) for PRA and IS of 4.7 and 3.9 min, respectively, at ambient temperature. The results were precise and repeatable for areas of the peaks and peak normalization ratio (PN PRA/PNIS). Linearity was found in the concentration range of 1.56-7.78 × 10-5 M. Intra-day and Inter-day assays were performed and reliable results were obtained. Limit of detection and limit of quantitation were 8 × 10-6 and 2.4 × 10-5 M, respectively. The proposed method was successfully applied for the analysis of PRA in the pharmaceutical tablet formulation. The method proved simple, precise and fast since the analysis can be performed in less than 5 min