Method development and validation of stability indicating rp hplc for estimation of mucolytic agent in combination with fluoroquinolones and cephalosporins drugs in pharmaceutical formulation

Abstract

Background: newlineIt is revealed that no stability indicating HPLC method is available for determination of Ambroxol hydrochloride in a combination with other Fluoroquinolones and Cephalosporins drug, after going through various reported and official methods. newlineAim: newlineAvailable methods in literature review have a problem with solvent stability and methods are more time-consuming. So there is a need for accurate stability indicating method for separation and estimation of Ambroxol hydrochloride in combination with Levofloxacin hemihydrate, in combination with Cefadroxil monohydrate, in combination with Cefixime trihydrate and in combination with Gemifloxacin mesylate. newlineMaterials and Methods: newlineReverse Phase High-Performance Liquid Chromatography method is used for stability indicating method of all combination of drugs. These methods describe a simple, specific, accurate and precise method and validated according to ICH guidelines. newlineResult and Discussion: newlineThis stability indicating HPLC methods for combination of Ambroxol hydrochloride with other drug is linear with an R2 value greater than 0.999. These methods are accurate with recovery between 98 % and 102%. All methods are rugged and precise with a RSD value below 1.0 %. All methods show different degradation in a different condition like acid hydrolysis, base hydrolysis, oxidative hydrolysis, UV, and heat. newlineConclusions: newlineThese methods applied to the marketed formulation of the combined dosage form. This stability indicating validated methods are useful and beneficial in industry. newline