title: Determination of Carvedilol Enantiomers in Pharmaceutical Dosages by SBSE-HPLC Based on Diastereomer Formation.
abstract: A sensitive, selective and simple method for the simultaneous determination of carvedilol enantiomers in aqueous solution has been developed using stir bar sorptive extraction (SBSE) followed by high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection. This method is based on the reaction of carvedilol enantiomers with (-)-menthyl chloroformate (MCF) after extraction by the SBSE method to produce diastereomeric derivatives. The separation was achieved by use of a C18 analytical column and the influence of mobile phase composition on the enantioseparation of carvedilol was studied. The applicability of two sorptive phases, poly(methyl methacrylate/ethyleneglycol dimethacrylate) (PA-EG) and polydimethylsiloxane, were tested for extraction of carvedilol enantiomers from aqueous samples. The obtained results showed excellent linear dynamic ranges and precisions for each of them. The least limit of detection for (S)- and (R)-carvedilol obtained 8 and 11 µg L(-1), respectively, using the PA-EG sorptive phase. Inter- and intra-mean recoveries were also satisfactory, ranging from 98 to 103%, with coefficient of variation in the range of 1-5% at three fortified levels using a PA-EG coated stir bar. The proposed SBSE (PA-EG)-MCF derivatization-HPLC-UV method was successfully applied to enantioselective analysis of carvedilol in water and pharmaceutical dosages, confirming the application of this method.
authors.affiliation: Department of Chemistry, Faculty of Science, Alzahra University, Vanak, Tehran, Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Taraji
authors.affiliation: Department of Chemistry, Faculty of Science, Alzahra University, Vanak, Tehran, Iran ztalebpour@yahoo.com.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Talebpour
authors.affiliation: Food and Drug Research Center, Ministry of Health, Tehran, Iran.
authors.forename: Nuoshin
authors.initials: N
authors.lastname: Adib
authors.affiliation: Department of Chemistry, Faculty of Science, Alzahra University, Vanak, Tehran, Iran.
authors.forename: Shima
authors.initials: S
authors.lastname: Karimi
authors.affiliation: Department of Chemistry, Faculty of Science, Alzahra University, Vanak, Tehran, Iran.
authors.forename: Farideh
authors.initials: F
authors.lastname: Haghighi
authors.affiliation: Pharmaceutical and Medicinal Chemistry Department, Pharmaceutical and Drug Industries Research Division, National Research Centre, Dokki 12622, Giza, Egypt.
authors.forename: Hassan Y
authors.initials: HY
authors.lastname: Aboul-Enein
mesh_terms: D002227:Carbazoles / Q000032:analysis* / Q000737:chemistry*; D000077261:Carvedilol; D005591:Chemical Fractionation / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D057230:Limit of Detection; D016014:Linear Models; D011412:Propanolamines / Q000032:analysis* / Q000737:chemistry*; D015203:Reproducibility of Results; D013237:Stereoisomerism
chemical_list: D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol