International journal of clinical pharmacology and therapeutics · 2005
A bioequivalence study of citalopram based on quantification by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry.
Клиническое исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Mendes G Duarte, Borges N Carter do Carmo, Pereira A dos Santos, Mendes F Duarte, Barrientos-Astigarraga R Eliseo, De Nucci G
Аннотация
OBJECTIVE: The aim of this study was to compare the bioavailability of two citalopram formulations (citalopram from Eurofarma Laboratórios Ltda., as the test formulation, and cipramil from Schering-Plough, Brazil, as the reference formulation) in healthy volunteers.
METHODS: The study had an open, randomized, two-period crossover design with a two-week washout interval between doses. The samples were obtained over a 168-hour interval after each oral administration of citalopram (one 20 mg tablet of each formulation). The analyte and the internal standard were extracted from plasma using diethylether: dichloromethane (70 : 30, v/v) and the extracts were analyzed by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry. Chromatography was done isocratically using a Genesis C8 analytical column (4 microm, 2.1 mm i.d. x 100 mm). The method had a chromatographic run time of three minutes and a linear calibration curve over the range of 0.5 - 200 ng x ml(-1) (r2 > 0.999887). The limit of quantification was 0.5 ng x ml(-1).
RESULTS: The geometric mean and 90% confidence intervals (CI) for the citalopram/cipramil ratio were 98.28% (94.24 - 102.49%) for AUClast, 96.44% (90.20 - 103.11%) for AUCinf, and 98.54% (94.70 - 102.54%) for Cmax.
CONCLUSION: Since the 90% CI for Cmax, AUClast and AUC(0-infinity) ratios were all within the 80 - 125% interval proposed by the US Food and Drug Administration, we concluded that the citalopram formulation elaborated by Eurofarma Laboratórios Ltda. was bioequivalent to the cipramil formulation in its rate and extent of absorption.
METHODS: The study had an open, randomized, two-period crossover design with a two-week washout interval between doses. The samples were obtained over a 168-hour interval after each oral administration of citalopram (one 20 mg tablet of each formulation). The analyte and the internal standard were extracted from plasma using diethylether: dichloromethane (70 : 30, v/v) and the extracts were analyzed by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry. Chromatography was done isocratically using a Genesis C8 analytical column (4 microm, 2.1 mm i.d. x 100 mm). The method had a chromatographic run time of three minutes and a linear calibration curve over the range of 0.5 - 200 ng x ml(-1) (r2 > 0.999887). The limit of quantification was 0.5 ng x ml(-1).
RESULTS: The geometric mean and 90% confidence intervals (CI) for the citalopram/cipramil ratio were 98.28% (94.24 - 102.49%) for AUClast, 96.44% (90.20 - 103.11%) for AUCinf, and 98.54% (94.70 - 102.54%) for Cmax.
CONCLUSION: Since the 90% CI for Cmax, AUClast and AUC(0-infinity) ratios were all within the 80 - 125% interval proposed by the US Food and Drug Administration, we concluded that the citalopram formulation elaborated by Eurofarma Laboratórios Ltda. was bioequivalent to the cipramil formulation in its rate and extent of absorption.