Abhijeet Ladke, Anita Ingle, Pranjali Ranaware, Mrinalini Damle
Abhijeet Ladke, Anita Ingle, Pranjali Ranaware and Mrinalini Damle*
Department of Quality Assurance, AISSMS College of Pharmacy, Pune - 411001, Maharashtra, India.
Volume - 5,
Issue - 5,
Year - 2012
Purpose: To develop and validate a simple and rapid stability-indicating HPLC method for rosuvastatin and fenofibrate in combination. Method: An isocratic RP-HPLC was developed using Jasco HPLC system with HiQ sil C18 HS (250 ?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.
Results: 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.
Conclusions: 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.
Cite this article:
Abhijeet Ladke, Anita Ingle, Pranjali Ranaware, Mrinalini Damle. Development and validation of stability indicating HPLC method for Rosuvastatin calcium and Fenofibrate in combination. Asian J. Research Chem. 5(5): May 2012; Page 606-610.