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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Simultaneous RP-HPLC Method Development and Validation of Atorvastatin, Ezetimibe and Fenofibrate

Abstract

Sahu PK, Murthy Pyla SR, Srinivas K and Swain S

A simple, accurate, precise and robust reverse phase high performance liquid chromatographic method has been developed and subsequently validated for the simultaneous estimation of atorvastatin (AT), ezetimibe (EZ) and fenofibrate (FE) in commercial formulation. The method has shown an adequate separation for AT, EZ and FE. The drugs were resolved on an enable C-18 Column (25 mm x 4.6 mm i.d, 5 μm particle size) using Shimadzu SPD-20A prominence UV-Visible detector with the mobile phase composed of acetonitrile and phosphate buffer (pH 3.3) in the ratio of 90:10% V/V as mobile phase at a flow rate of 1 mL/min and the detection was carried out at 254 nm. The retention time of AT, EZ and FE were found to be 3.155, 5.299 and 6.215 min respectively. The linearity of the proposed method was investigated in the range of 10-100 μg/mL, 10-100 μg/mL, and 160-1600 μg/mL for AT, EZ and FE, respectively. The limit of detection (LOD) was 2.18, 0.87, and 20.9 for AT, EZ and FE, respectively. The limit of quantification (LOQ) was 6.8, 2.6 and 63.6 for AT, EZ and FE, respectively. The % RSD from the precision and accuracy studies was found to be below 2%. The proposed method was statistically evaluated and can be applied in regular quality control of AT, EZ and FE in pharmaceutical dosage forms.

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Citations: 533

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