Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
Vol. 12, No. 1, 2013, pp. 93-97
Bioline Code: pr13015
Full paper language: English
Document type: Research Article
Document available free of charge
Tropical Journal of Pharmaceutical Research, Vol. 12, No. 1, 2013, pp. 93-97
© Copyright 2013 - Tropical Journal of Pharmaceutical Research
Facile Colorimetric Determination of Duloxetine in Formulations Using Methyl Orange as Ion-Pairing Agent|
Hemalatha, Pushparaj; Ganesh, Mani; Peng, Mei Mei & Jang, Hyun Tae
Purpose: To develop a new and fully validated ion-pair spectrophotometric method for the
determination of duloxetine hydrochloride (DX).
Methods: Ion-pair spectrophotometric method was employed for the determination of duloxetine
hydrochloride (DX) in bulk and pharmaceutical formulations using acidic dye methyl orange (MO) as
ion-pairing agent at pH 4 (phthalate buffer). The yellow ion-pair complex was extracted with chloroform
and spectrophotometrically estimated at 420 nm. The developed method was validated according to
ICH and USP guidelines.
Results: The ion-pair complex of DX and MO obeyed Beer’s law in the range of 2 - 20 μg mL-1 of DX
with a correlation coefficient of 0.998. Recovery was good, with a relative standard deviation (%RSD) of
0.88 - 1.02; precision (inter-day, 0.878 and intra-day, 0.921) was also within validation limits. The limit of
detection (LOD) and limit of quantitation (LOQ) were 0.25 and 4 μg mL-1, respectively. The method
developed was successfully applied to determine DX in a formulation.
Conclusion: The developed method is accurate, precise, rugged, robust and reproducible. It is also
sensitive and specific for the determination of DX in bulk and formulation.
Duloxetine, Methyl orange, Ion-pair, Validation, Spectrophotometry
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