Adv Pharm Bull. 2014;4(4):405-411.
doi: 10.5681/apb.2014.060
PMID: 25436199
PMCID: PMC4137433
  Abstract View: 369
  PDF Download: 227

Short Communication

Stability Indicating Liquid Chromatographic Method for the Simultaneous Determination of Rosuvastatin and Ezetimibe in Pharmaceutical Formulations

Mathrusri Annapurna Mukthinuthalapati 1 * , Venkatesh Bukkapatnam 1, Sai Pavan Kumar Bandaru 1

1 Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, India.

Abstract

Purpose: A simple stability indicating reverse phase liquid chromatographic method was developed for the simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical formulations. Methods: Best chromatographic response was achieved with C18 column (250 X 4.6 mm, 5μm) with photo diode array (PDA) detector. The mobile phase was composed of a mixture of sodium acetate buffer (pH 4.0) and acetonitrile (30:70, %v/v) with a flow rate of 1.2 mL/min. (UV detection at 254 nm). Rosuvastatin and ezetimibe were subjected to stress conditions of degradation and the method was validated as per ICH guidelines. Results: The method shows linearity over a concentration range of 0.5–250 μg/ml for both rosuvastatin (r2 = 0.9993) and ezetimibe (r2 = 0.9996). Both the drugs are highly sensitive towards alkaline conditions in comparison to other stress conditions. Conclusion: The proposed method can be successfully applied to perform long-term and accelerated stability studies for the simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical formulations.
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Submitted: 07 Jan 2014
Revised: 19 Mar 2014
First published online: 10 Aug 2014
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