Liquid Chromatographic Determination of Atorvastatin in Bulk Drug, Tablets, and Human Plasma

Abstract

A simple, specific, and accurate high performance liquid chromatographic (HPLC) method for determination of atorvastatin in bulk drug, tablets, and human plasma have been developed. Liquid chromatography was performed on a RP‐Supelcosil C18 (5 µm, 150 × 4.6 mm) column and the mobile phase consisted of an acetonitrile:methanol:water (45:45:10 v/v/v), and a flow rate of 1.0 mL/min. The effluent was monitored on a UV detector at 240 nm. Each analysis required no longer than 3.0 min. Quantification was achieved by the measurement of the peak area ratio of the drug to the internal standard (ibuprofen). For quantification, a calibration curve was constructed for atorvastatin concentration ranging between 0.5–86.0 µg/mL. Furthermore, the typical excipients included in the drug formulation (starch, lactose, glucose, sugar, talc, sodium chloride, titanium dioxide, and magnesium stearate) do not interfere with the selectivity of the method. Data, with respect to precision and accuracy and limits of detection, are reported and discussed. The proposed chromatographic method was successfully applied to the quantitative determination of atorvastatin in bulk drug, tablets, and spiked human plasma.