Dissolution Method for Milnacipran Hydrochloride Capsules: Development, Validation, and Study of Changes in Dissolution Rate after Storage

摘要

A dissolution test for milnacipran hydrochloride capsules was developed and validated according to international guidelines. After selection of the best conditions, the method was validated using USP Apparatus 1 (baskets), 50-rpm rotation speed, 900 mL of 0.01 N HCI,and test time of 60 min.The drug released was determined by both LC-UV (PDA) and UV-D~2 methods.The kinetic parameters of drug release (mathematical models, t_(80), and dissolution efficiency) were investigated, and the stability of the dosage form was evaluated by analyzing changes in the dissolution rate of milnacipran hydrochloride capsules during storage at 40 癈 and 75 RH for different periods.