Determination of Carvedilol in Human Plasma by Gas Chromatography-Mass Spectrometry Method

An analytical procedure was developed and validated for the quantitation of carvedilol in human plasma. Carvedilol and atenolol (internal standard) were extracted from human plasma with a mixture of diethylether and ethylacetate at basic pH with liquid-liquid extraction. The extracts were derivatized with n-Methyl-n-(trimethylsilyl)trifluoroacetamide and analyzed by gas chromatography-mass spectrometry (GC-MS). Calibration curves were linear over the concentration range 15-500 ng/mL Intra-and inter-day precision, expressed as the relative standard deviation were less than 8.0%, and accuracy (relative error) was better than 11.0%. The limits of detection and quantification of carvedilol were 5.0 and 15 ng/mL, respectively. Also, the method was successfully applied to three patients with hypertension who had been given an oral tablet of 25 mg carvedilol.