Development and Validation of a Simple UV Method for In Vitro Determination of Amoxicillin Trihydrate in New Gastroretentive Dosage Form

摘要

A simple, rapid, sensitive and robust UV method was developed and validated to measure the amount of amoxicillin in order to assess drug release profiles and drug-excipients compatibility studies for new Gastroretentive Dosage Form and its subsequent stability studies. The working conditions of the method were investigated and optimized. The linearity for concentrations 5 to 30 μg/ml was established and the system founded to obey Beer-Lambert's law in this concentration range. Intra and inter-day precision were less than 2.5%. The limits of detection (LOD) and quantitation were 0.58 and 1.77 ig/ml. The determination of the active ingredient was not interfered by the excipients of the products. Samples were stable in the release media (37 ± 0.5 °C). The proposed method is simple, sensitive, accurate and suitable for quality control applications.