Development and Validation of an Ultraviolet Visible Spectroscopy Method in Vitro Determination of Flucloxacillin Capsule

The objective of the present study was to develop and validate a discriminative dissolution method for evaluation of Flucloxacillin Sodium as Flucloxacillin. Different conditions such as type of dissolution medium, volume of dissolution medium and rotation speed of paddle were evaluated. The best in vitro dissolution profile was obtained using Apparatus II (paddle), 75 rpm, 900 ml of pH 6.8 phosphate buffer as dissolution medium. The drug release was evaluated by UV-Visible Spectrophotometer method. The dissolution method was validated according to current ICH and FDA guidelines using parameters such as the specificity, accuracy, precision and stability were evaluated and obtained results were within the acceptable range. A simple, selective, rapid, and precise UV-Visible Spectrophotometer method has been developed for the in vitro determination of Flucloxacillin from dosage forms.