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