Quantification of cyproheptadine in human plasma by high‐performance liquid chromatography coupled to electrospray tandem mass spectrometry in a bioequivalence study

• DOI: 10.1002/bmc.1618
• Publication Date: 2011-03-23T07:29:37Z
• Authors: Gustavo Duarte Me...; André Arruda; Lu Shi Chen; José Cássio de Al...; Khalid M Alkharfy; Gilberto De Nucci
• Keywords: Cyproheptadine; Bioequivalence

A rapid, sensitive and specific method to quantify cyproheptadine in human plasma using amitriptyline as the internal standard (IS) is described. The analyte IS were extracted from by liquid-liquid extraction a diethyl-ether/dichloromethane (70/30; v/v) solvent. After removing drying organic phase, extracts reconstituted with fixed volume of acetonitrile/water (50/50 v/v)+0.1% acetic acid. analyzed high performance liquid chromatography coupled electrospray tandem mass spectrometry (LC-MS/MS). Chromatography was performed isocratically an Alltech Prevail C18 5 µm analytical column, (150 mm x 4.6 I.D.). had chromatographic run time 4 min linear calibration curve ranging 0.05 10 ng/mL (r2 > 0.99). limit quantification ng/mL. This HPLC/MS/MS procedure used assess bioequivalence two + cobamamide (4 mg 1 mg) tablet formulations (Cobactin® [cyproheptadine cobamamide] test formulation supplied Zambon Laboratórios Farmacêuticos Ltda. Cobavital® Solvay Farma (standard reference formulation)). single dose each administered healthy volunteers. study conducted open, randomized, two-period crossover design 1-week washout interval. Since 90% CI for Cmax AUCs ratios all within 80-125% proposed US Food Drug Administration, it concluded that (Cobactin®) bioequivalent both rate extent absorption cyproheptadine.