New Validated Stability-Indicating Rp-HPLC Method for Simultaneous Estimation of Atorvastatin and Ezetimibe in Human Plasma by Using PDA Detector.
OBJECTIVE
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.


CONCLUSIONS
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.
Department of Pharmaceutical Analysis and Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P.
S Ashutosh
SA
Kumar
Department of Pharmaceutics, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P.
Manidipa
M
Debnath
Srinivasarao College of Pharmacy, Pothinamallayyapalem, Madhurawada, Visakhapatnam, 530041, A.P.
J V L N Seshagiri
JV
Rao
College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, 530003, A.P.
D Gowri
DG
Sankar
Atorvastatin; Ezetimibe; ICH Guideline; LLOQ; Plasma; RP-HPLC