Method Development and Validation Studies for Gemifloxacin In Vitro Release Profile: an Application to Quality Attributes

The purpose of the present investigation is to develop the dissolution method for gemifloxacin as no monograph in pharmacopoeia is available for drug release estimation. Moreover, to calculate various quality characteristics of gemifloxacin 320 mg tablets (GEM-1 to GEM-5) accessible in local market place, Karachi Pakistan. Selected brands were purchased from retail pharmacies. Several physic-chemical features of reference brand (GEM-4) and test (GEM-1 to GEM-5) brands were determined to elucidate the related quality attributes of all formulations. Moreover, pharmaceutical equivalence tests were also carried out including identification, dissolution (%Q(80)), disintegration potential, drug recoveries (assay) and content uniformity. While therapeutic equivalence in vitro estimation of all brands were executed by dissolution (multiple point) test using developed and validated dissolution media composed of buffer pH 1.2. Results were analyzed with one way ANOVA approach, model-independent and dependent techniques. Suggested method was found suitable and applicable to routine quality testing. While brand comparison study reveals the pharmaceutical equivalence of selected products available in local market.