Reverse phase LC method for in vitro dissolution test for determination of Bromazepam from tablet formulations

摘要

Bromazepam is a benzodiazepine (BZD) generally used for a number of medical reasons, it is an intermidiate-acting tranquiliser (Ashton H, 2005), prescribed for the treatment of moderate to severe anxiety and panic attacks for the short-term treatment of insomnia.ududIt has been widely used in psychiatry disorders for four decades, with selective anxiolytic, anticonvulsant, myorelaxant and hypnotic actions. It acts on the central neural system as an inhibitor of the neurotransmitter gamma aminobutyric acid (GABA). (Guilherme Nobre Lima do Nascimento et al. 2012)ududIt is a drug that belongs to class of 1,4-benzodiazepine and chemically corresponds to 7-bromo-1,3-dihydro-5-(2-pyridyl)-2H-1,4-benzodiazepine-2-one, C₁₄H₁₀BrN₃O. (Ph.Eur 7th, 2010). It is a controlled psychotropic substance-B1 class according National Agency of Sanitary Vigilance in Brazil (ANVISA), with the DCB identification numbers: 01366, DCI: 2692 and CAS: 1812-20-2. The solid form is the widespread used and prescribed in clinical practice. The solid form shows problems associated to the bioavailability, (FDA, 2003) indeed; the absorption of oral drugs in the solid form depends on the solubility and dissolution in physiologic liquids and its permeability through the gastrointestinal tract, factors that influence directly its bioavailability and subsequent pharmacological effects. The biotransformation from solid into absorbable form depends on its dissolution in organic liquids; therefore, dissolution tests became an essential parameter to determine the properties of biopharmaceutical formulations in order to predict their quality. The quality of pharmaceutical formulations is important in financial and ethical terms because it is directly associated with the patient’s health. Thus, there is a real need for the development of dissolution tests able to predict in vivo physiological behavior.ud