title: Bioanalytical Method Validation for Dronedarone and Duloxetine in Blood Serum.
abstract: The present work relates to the development and validation of reversed-phase HPLC-UV-photodiode array methods for the estimation of two drugs in blood serum: dronedarone hydrochloride (DDN), a class III antiarrhythmic drug, and duloxetine hydrochloride (DLX), an antidepressant. Chromatographic analysis of DLX was carried out on a Nucleodur C18 column (250 × 4.6 mm, 5 μm) using ammonium acetate buffer (32 mM, pH 5.5) and acetonitrile (40 + 60, v/v; flow rate of 1.0 mL/min; detection wavelength of 290 nm) as the mobile phase. A Waters XTerra C18 column (250 × 4.6 mm, 5 μm) was used for the chromatographic analysis of DDN using an acetonitrile-ammonium formate buffer (20 mM, pH 3.0, with formic acid; 45 + 55, v/v; flow rate 1.0 mL/min) as the mobile phase. Pentazocine and bupropion HCl were used as the internal reference standards for DLX and DDN, respectively. Excellent linearity was observed for DLX (r2 = 0.9996; concentration range 0.2-10.0 μg/mL) and DDN (r2 = 0.9997; concn. range 2.0-50.0 μg/mL). The LODs for DLX and DDN were 0.022 and 0.78 μg/mL, respectively, and the LOQs 0.066 and 2.4 μg/mL, respectively.
authors.affiliation: Panjab University, University Institute of Pharmaceutical Sciences, University Grants Commission, Center of Advanced Study, Chandigarh 160014, India.
authors.forename: Renu
authors.initials: R
authors.lastname: Chadha
authors.affiliation: Panjab University, University Institute of Pharmaceutical Sciences, University Grants Commission, Center of Advanced Study, Chandigarh 160014, India.
authors.forename: Alka
authors.initials: A
authors.lastname: Bali
authors.affiliation: Punjabi University, Department of Pharmaceutical Sciences and Drug Research, Patiala, Punjab 147002, India.
authors.forename: Gulshan
authors.initials: G
authors.lastname: Bansal
mesh_terms: D000638:Amiodarone / Q000031:analogs & derivatives* / Q000097:blood; D002851:Chromatography, High Pressure Liquid; D000077764:Dronedarone; D000068736:Duloxetine Hydrochloride / Q000097:blood*; D006801:Humans; D044967:Serum / Q000737:chemistry
chemical_list: D000068736:Duloxetine Hydrochloride; D000077764:Dronedarone; D000638:Amiodarone