RS Method for Quantification of Imeglimin HCl in Its Pure and Tablet Dosage form by using RP-HPLC Technology

Abstract

This study focused on developing and characterizing floating microspheres of Propranolol HCl, aiming to enhance gastric retention and sustained drug release. A UV-Visible spectrophotometric method was validated for drug quantification in 0.1N HCl at 256 nm, exhibiting strong linearity over the concentration range of 2 to 10 µg/ml. Compatibility studies using FTIR spectroscopy confirmed no chemical interactions between the drug and polymers, ensuring formulation stability. The prepared microspheres showed high percentage yields between 81.58% and 95.50%, with drug entrapment efficiency improving as polymer concentration increased due to higher solution viscosity reducing drug diffusion during formation. Further evaluations revealed that the microspheres exhibited satisfactory swelling behavior and mucoadhesive properties essential for prolonged gastric residence. In vitro release experiments demonstrated efficient and controlled drug liberation over 12 hours, with release kinetics fitting diffusion-controlled models such as zero-order, first-order, Higuchi, and Korsmeyer-Peppas. Optimized formulations showed promising potential for sustained release and enhanced gastroretention, which could improve therapeutic effectiveness and patient adherence.