Abstract
This paper describes a simple, precise and accurate RP-HPLC method for simultaneous estimation of atorvastatin and ezetimibe in plasma. 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. 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. 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.
Highlights
Atorvastatin (ATV)[1] is chemically [R-(R*, R*)]-2-(4flurophenyl)-β, δ-dihydroxy-5- (1-methylethyl)-3-phenyl4-[(phenyl amino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt trihydrate
LC and UPLC MS-MS simultaneous determination of atorvastatin and ezetimibe in human plasma were reported in the literature.[14,15]
It was found that, there are lots of chromatographic methods available for the simultaneous estimation of atorvastatin and ezetimibe in their combined dosage form along with other drugs ; this work holds a challenge for developing a new method in high performance liquid chromatography
Summary
Atorvastatin (ATV)[1] is chemically [R-(R*, R*)]-2-(4flurophenyl)-β, δ-dihydroxy-5- (1-methylethyl)-3-phenyl4-[(phenyl amino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt trihydrate. Preparation of standard solution of atorvastatin and ezetimibe About 10 mg atorvastatin was weighed accurately and transferred into a 100 mL clean and dry volumetric flask. From the above prepared stock solutions 1.5 mL of atorvastatin and 1.5 mL ezetimibe were pipetted out into a 10 mL clean and dry volumetric flask and it was diluted up to the mark with diluent.
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