title: Development and validation of a stability-indicating liquid chromatography method for the determination of dabigatran etexilate in capsules.
abstract: An RP-LC method was developed and validated for the determination of dabigatran etexilate in a capsule formulation. The LC method was carried out on a Zorbax C18 column (250 x 4.6 mm id). The mobile phase consisted of acetonitrile and a solution of triethylamine 0.1%, pH 6.0 adjusted with phosphoric acid (65 + 35, v/v) at a flow rate of 1.0 mL/min. The diode array detector was set at 225 nm. The chromatographic separation was obtained with retention time of 6.31 min, and linearity was in the range of 10-70 microg/mL (R2 = 0.9991). The specificity and stability-indicating capability of the method was proven through degradation studies and showing that there was no interference from the excipients. The accuracy was 100.23%, with an RSD of 1.34%. The LOD and LOQ were 0.04 and 10 microg/mL, respectively. Moreover, method validation demonstrated acceptable results for robustness and a system suitability test. The proposed method was applied for the analysis of the capsules to ensure their therapeutic efficacy.
authors.affiliation: Federal University of Rio Grande do Sul, Faculty of Pharmacy, Postgraduate Program in Pharmaceutical Sciences, 90610-000 Porto Alegre-RS, Brazil. raquel.bernardi@yahoo.com.br
authors.forename: Raquel M
authors.initials: RM
authors.lastname: Bernardi
authors.forename: Pedro E
authors.initials: PE
authors.lastname: Fröehlich
authors.forename: Ana M
authors.initials: AM
authors.lastname: Bergold
mesh_terms: D000991:Antithrombins / Q000032:analysis*; D001562:Benzimidazoles / Q000032:analysis*; D002214:Capsules; D002853:Chromatography, Liquid / Q000379:methods*; D000069604:Dabigatran; D057230:Limit of Detection; D011725:Pyridines / Q000032:analysis*
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D002214:Capsules; D011725:Pyridines; D000069604:Dabigatran