Determination of in vitro drug release of amoxycillin and potassium clavulanate tablets ip as per indian pharmacopoeia

Infections still represent a common cause of morbidity and mortality worldwide accounting among the most important reasons for hospital admissions and increased economic burdens for national health system in India. Amoxycillin and Potassium clavulanate is an oral antibacterial combination consisting of the semisynthetic antibiotic Amoxycillin and the β-lactamase inhibitor, clavulanate potassium. In-vitro drug release testing, a measure of release of the active pharmaceutical ingredient (API) from the drug product matrix in controlled laboratory environment, is a key evaluation in drug development and quality control. It involves subjecting the dosage form to a set of conditions that will induce drug release and quantitating the amount of drug released under those conditions. In vitro dissolution testing of oral dosage forms measures the dissolution rate of an amount of drug substance going from the solid state into solution per unit time under standardized conditions. The goals of a dissolution test include prediction of bioavailability, indication of drug product safety of dosage form and implication of variations in the manufacturing process. The main objective of this research work is to evaluate the quality of two brands of Amoycillin and Potassium Clavulanate Tablets IP mg marketed in North East region of India, in order to verify whether these products complies with the standard monograph or not.