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New Validated Stability-Indicating Rp-HPLC Method for Simultaneous Estimation of Atorvastatin and Ezetimibe in Human
S Ashutosh Kumar1, Manidipa Debnath2, J V L N Seshagiri Rao3
1Department of Pharmaceutical Analysis and Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P.
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.
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