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THE PHARMA REVIEW (JUNE 2008)

Development and Validation of New RP-HPLC Method with UV-Detection for the Determination of Carvedilol in Human Serum

Mogallapalli L V Setti, Vijaya Ratna J

Abstract: Carvedilol is mainly used as an antihypertensive drug and it also possesses antioxidant and antiproliferative effects. A simple and sensitive analytical method was developed for carvedilol in human serum by using high performance liquid chromatography (HPLC). The method employs a liquid- liquid extraction for isolation and sample concentration followed by reversed phase liquid chromatography (RPLC) analysis using ultraviolet (UV) detection at 241 nm. Analytes were extracted from serum samples that were previously mixed with sodium hydroxide solution into an n- hexane, dichloromethane (7:3) solvent system. The mobile phase consisted of acetonitrile: orthophosphoric acid (37:63). The filtered mobile phase components were pumped from the respective reservoirs at a flow rate of 1.0 mL/min. Celecoxib was used as internal standard. Serum samples containing the carvedilol and internal standard, celecoxib were eluted through a C18 column. Retention times of carvedilol and celecoxib are 9.12 min and 11.49 min, respectively. The limit of detection of the drug in serum is 5 500 ng/ml. The extraction recovery of carvedilol is more than 75%. The intra day and inter day coefficient of variation and percent error values of the assay method were less than 5 %. Such a method would be ideally suitable for the estimation of carvedilol in pharmacokinetic studies after administration of carvedilol formulations.

Introduction
Carvedilol, (+)-1-(Carbaz ol-4-yloxy)-3-{[ 2-(o-methoxyphenoxy)ethyl] amino}- 2-propanol (Figure 1), is a b receptor blocker and is an antihypertensive drug with a multiple action spectrum, and it also has vasodilating properties that are attributed mainly to its blocking activity at a1 receptors. Carvedilol is used in the treatment of mild to moderate hypertension and angina pectoris. Carvedilol undergoes extensive first pass metabolism that results in an absolute bioavailability of about 25%.

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