Abstract
A sensitive, precise, and simple HPLC method was developed for the simultaneous quantification of rosuvastatin and fenofibric acid in rat plasma. The chromatographic separation was achieved on a C18 (250 mm × 4.6 mm, 5 mm) column maintained at room temperature, using isocratic elution with acetonitrile:0.1%disodium hydrogen orthophosphate buffer (50:50%, v/v) and detected using UV-Visible detector at a UV wavelength of 248 nm. The liquid–liquid extraction of both the drugs from rat plasma with ethyl acetate resulted in their high recoveries (≥80%). HPLC calibration curves based on the extracts from the rat plasma were linear in the range of 50–3000 ng/mL for rosuvastatin and 100–6000 ng/mL for fenofibric acid. The lower limits of quantification were 50 and 100 ng/mL for rosuvastatin and fenofibric acid, respectively. The precision and accuracy of the method were well within the accepted criteria (±15%) for biomedical analysis. Stability studies showed that both the drugs were stable in rat plasma for short- and long-term period for sample preparation and analysis. The described method was successfully applied to study the pharmacokinetics of rosuvastatin and fenofibrate in Sprague–Dawley rats following a single dose, oral administration in combination. The application of the method confirmed its utility.
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