Development and validation of stability indicating HPLC method for rosuvastatin calcium and fenofibrate in combination.

To develop and validate a simple and rapid stability-indicating HPLC method for rosuvastatin and fenofibrate in combination.

An isocratic RP-HPLC was developed using Jasco HPLC system with HiQ sil C18 HS (250 X 4.6 mm i.d, 5 μm particle size) column with the mobile phase containing mixture of acetonitrile:water (pH 4.0, adjusted with o-phosphoric acid) (70: 30% v/v). The flow rate was 1.5ml/min and the eluent was monitored at 287nm. The proposed method was validated as per ICH guidelines.

The retention time for rosuvastatin calcium and fenofibrate were 2.28min and 13.06min respectively. The assays exhibited good linearity (r²>0.99) over the studied in a range of 1–10μg/ml. The stress testing of rosuvastatin and fenofibrate was carried out under acidic, alkaline, oxidative, neutral, photolytic and thermal conditions. Rosuvastatin and fenofibrate were well resolved from respective degradation products.

The results indicated that this method is a simple, rapid, precise and accurate for determination of rosuvastatin and fenofibrate in bulk and in pharmaceutical dosage forms as well as for the stability studies.