Quantitative determination of pravastatin in pharmaceutical dosage forms by high-performance liquid chromatography with ultraviolet detection.

A simple, sensitive and precise high-performance liquid chromatographic formulations assay for pravastatin (PVS) is described. Good chromatographic separation was achieved using a Teknokroma C8 (5 μm, 25cm × 4.6mm) column and a mobile phase consisting of 10mM ammonium acetate: methanol: triethylamine (40:60:0.17 v/v/v) while at a flow-rate of 1.0 mL min(-1). PVS was detected at 239 nm and was eluted 2.15 min after injection. No endogenous substances were found to interfere. No internal standard was required. Linearity range for PVS was 0.4-1000 μg mL(-1). The determination of intra- and inter-day precision (RSD) was less than 2.94 and 2.97%, at all concentration levels. Statistical treatment of the experimental results indicates that the method is precise and accurate. The proposed method was applied to the determination of the component in commercial tablets with no interference from the excipients. A comparative study between the suggested procedure and the pharmacopoeial method for this compound in the tablets showed no significant difference between the two methods.