Analytical Method Development and Validation by UV and HPLC Techniques

Gemifloxacin,a flouroquinoline derivative has antibacterial activity. Ambroxol dibromoaminobenzyl derivatives have mucolytic activity.GEM and AMB are available in tablet dosage form (G-cin A,Lupin)for mucolytic action. The present work dealt with simultaneous estimation of GEM and AMB from bulk and tablet formulation by different UV spectrophotometric, RPHPLC and Dissolution techniques. Five UV methods were developed which are accurate, precise, rapid and economical for the estimation of GEM and AMB in Tablet dosage form. The developed HPLC method was validated in terms of accuracy, repeatability, and precision. A good linear relationship was observed for GEM An attempt has been made to carry out the dissolution study of the marketed formulation by applying four established UV-Visible Spectrophotometric methods for estimation of % release of the drug (GEM & AMB).