Mathrusri Annapurna Mukthinuthalapati
1*, Venkatesh Bukkapatnam
1, Sai Pavan Kumar Bandaru
11 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.