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A simple, rapid and fully validated HPLC method for simultaneous quantitative bio‐analysis of rosuvastatin and candesartan in rat plasma: Application to pharmacokinetic interaction study
Author(s) -
Patel Misari,
Kothari Charmy
Publication year - 2019
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.4607
Subject(s) - candesartan , chemistry , chromatography , analyte , calibration curve , factorial experiment , rosuvastatin , fractional factorial design , pharmacokinetics , extraction (chemistry) , rosuvastatin calcium , sodium acetate , high performance liquid chromatography , acetonitrile , detection limit , angiotensin ii , pharmacology , mathematics , medicine , biochemistry , statistics , receptor
Abstract A simple, precise and accurate HPLC method was developed, optimized and validated for simultaneous determination of rosuvastatin and candesartan in rat plasma using atorvastatin as an internal standard. Solid‐phase extraction was used for sample cleanup and its subsequent optimization was carried out to achieve higher extraction efficiency and to eliminate matrix effect. A quality by design approach was used, wherein three‐level factorial design was applied for optimization of mobile phase composition and for assessing the effect of pH of the mobile phase using Design Expert Software. Adequate separation for both analytes was achieved with a Waters C 18 column (250 × 4.6 mm, 5 μm) using acetonitrile–5 m m sodium acetate buffer (70:30, v /v; pH adjusted to 3.5 with acetic acid) as a mobile phase at a flow rate of 1.0 mL/min and wavelength of 254 nm. The calibration curves were linear over the concentration ranges 5–150 and 10–300 ng/mL for rosuvastatin (ROS) and candesartan (CAN), respectively. The validated method was successfully applied to a pharmacokinetic study in Wistar rats and the data did not reveal any evidence for a potential drug–drug interaction between ROS and CAN. This information provides evidence for clinical rational use of ROS and CAN.