Development, validation of liquid chromatography-tandem mass spectrometry method for simultaneous determination of rosuvastatin and metformin in human plasma and its application to a pharmacokinetic study

Abstract

A new, simple and accurate liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of rosuvastatin (ROS) and metformin (MET) in human plasma was developed. The assay procedure involved simple protein precipitation with acetonitrile. Following precipitation, fraction of supernatant was decanted and evaporated under gentle stream of nitrogen at 40°C. The residue was reconstituted in mobile phase and injected. The chromatographic separation was achieved with Thermo Hypurity C18 column (50 mm × 4.6 mm, 5 μ) using a mobile phase composition containing 0.1% v/v formic acid in water and acetonitrile (30:70, v/v) at a flow rate of 0.4 mL/min. The total run time was 3.5 min. The method showed good linearity in the range 0.5–200 ng/mL for ROS and 2–2000 ng/mL for MET with correlation coefficient (r) >0.9994 for both the analytes. The intra and inter-day precision values for ROS and MET met the acceptance criteria as per regulatory guidelines. The battery of stability studies viz., bench-top, freeze-thaw and long term stability were performed. The developed method was applied to a pharmacokinetic study.

Analytical Methods for the Determination of Rosuvastatin in Pharmaceutical Formulations and Biological Fluids: A Critical Review

“…However, other analytical and bioanalytical methods demonstrated higher sensitivity values ranging from 0.05 mg/mL to 30 mg/ mL. Table 4 [56,[108][109][110][111][112][113][114][115][116][117][118][119][120][121][122][123][124][125] shows the LC-MS/MS methods developed for ROS analysis alone or in combination with other drugs determined in biological fluids. Most LC-MS/MS analyses were performed in positive ion mode (ESI C ) for the quantification of ROS in human plasma.…”

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“…Literature survey revealed that rosuvastatin calcium has been determined by spectrophotometric methods [4][5] , complexometric titration method 6 , LC-MS 7 , Stability indicating methods [8][9][10][11] , RP-HPLC [12][13][14][15] etc. Present study involves development and validation of a simple RP-HPLC method for the determination of rosuvastatin calcium from its transdermal dosage form.…”

Metformin - A Panacea Pharmaceutical Agent through convergence revolution initiative

“…High performance liquid chromatography [9][10][11] is now considered as the method of choice for the assay of metformin because of its simplicity, rapidity, high specificity, reproducibility and sensitivity. Quite recently the plasma concentration of metformin is being determined using Liquid chromatography tandem mass spectroscopy (LC-MS/MS System) 12 .…”