Abstract
Purpose: This paper describes a simple, precise and accurate
RP-HPLC method for simultaneous estimation of atorvastatin and ezetimibe in
plasma.
Methods: The chromatographic separation of the drugs were
performed on an X-Terra C8 (4.6 x 150 mm, 3.5 mm), with phosphate buffer [pH 3.5 with Ortho Phosphoric
Acid] – acetonitrile 40:60 (v/v) as mobile phase. The detection was performed
at 235 nm. The flow rate was maintained at 1.2 mL/min. The run time was 8.0
min.
Results: The accuracy and reliability of the method was
assessed by evaluation of linearity (5-25 µg/mL for both atorvastatin calcium
and ezetimibe), precision (intra-day RSD 0.57 % and inter-day RSD 0.02 % for
atorvastatin calcium and intra-day RSD 0.56 % and inter-day RSD 0.1 % for
ezetimibe), accuracy (100.08- 100.84 % for atorvastatin calcium and 100.56-
101.00 % for ezetimibe), and specificity, in accordance with ICH guidelines.
The LLOQ obtained by the proposed method were 1.294 and 1.384 µg/mL for
atorvastatin and ezetimibe respectively.
Conclusion: Overall the
proposed method was found to be suitable and accurate for the quantitative
determination in plasma. The method was effectively separated the drug from
plasma.