Development & validation of an in vitro dissolution method with HPLC analysis for misoprostol in formulated dosage form

Abstract

The intended purpose of this work is to develop and validate a dissolution test for misoprostol tablets containing 200 μg misoprostol [1% in hydroxypropyl methylcellulose {HPMC}] using a reverse-phase liquid chromatographic method. After testing sink conditions, dissolution medium and stability of the drug, the best conditions were: paddle at 50 rotations per minute (rpm) stirring speed, deaerated water dissolution medium with volume of 500 ml, as per very low label content of the drug substance & drug product. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, precision, linearity and accuracy. Release of more than 85% of the label amount was achieved over 30 min in the medium through out the study. The dissolution test developed was adequate for its purpose and could be applied for quality control of misoprostol formulation dosage form.