Quality control studies on conventional carbamazepine tablets available in the Indian drug market

Abstract

Carbamazepine (CBZ) is widely used as an antiepileptic drug, primarily for the treatment of partial and tonic-clonic seizures. The drug is absorbed slowly and variably after oral administration due to its limited water solubility. In clinics, single daily dosing of conventional dosage forms of CBZ is insufficient; effective CBZ levels are provided by multiple-dose administration. Multiplicity of dosage causes inconsistent plasma CBZ levels leading to side effects because of its narrow therapeutic and toxicity levels. The main aim of this paper is to compare four commercial brands of carbamazepine tablets that are available in the Indian drug market. Different quality control parameters such as weight variation, diameter and thickness, content uniformity, friability, and dissolution profiles were tested.Difference (f1) and similarity (f2) data analyses were carried out to demonstrate the differences between these commercial brands. The results of weight variations, diameter and thickness, content uniformity, and friability are comparable to the acceptable standard limits described by pharmacopeias such as USP. Though differences for release profiles exist, all the commercial brands released 75% of drug labeled amount within 1 hr according to USP, so they can satisfy patient need.