Journal :   Asian Journal of Research in Chemistry

Volume No. :   5

Issue No. :  5

Year :  2012

Pages :   606-610

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Development and validation of stability indicating HPLC method for Rosuvastatin calcium and Fenofibrate in combination



Address:   Abhijeet Ladke, Anita Ingle, Pranjali Ranaware and Mrinalini Damle*
Department of Quality Assurance, AISSMS College of Pharmacy, Pune - 411001, Maharashtra, India.
*Corresponding Author
DOI No:

ABSTRACT:
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.
KEYWORDS:
Rosuvastatin calcium, fenofibrate, Stress testing, Stability indicating method, HPLC.
Cite:
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.
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