Determination of Chemical Stability of Various Famotidine Dosage Forms by UV –Visible Spectrophotometric Method and Data Analysis by R-GUI Stability Software

作者: Erum Zaheer , Sohail Hassan , Iyad Naeem Muhammad , Amir Hassan , Mohsin Ali

DOI: 10.6000/1927-5129.2015.11.33

关键词: Dosage formFirst lineUpper gastrointestinalGastro esophageal refluxHigh-performance liquid chromatographyChemical stabilityFamotidineSuspension (vehicle)ChemistryChromatography

摘要: H 2 receptor antagonists are still the first line of therapy in treating gastro esophageal reflux diseases as well other ulcers upper gastrointestinal tract. Accelerated stability studies different brands Famotidine tablets (20mg) and suspension(10mg/5ml),both liquid dry, were carried out at 40 o C ± (Temperature) 75% R.H. 5% The assay was conducted by both HPLC UV/Visible Spectrophotometric methods whereas for suspensions only method used. tests 0, 1, 3 6 months per guidelines ICH accelerated studies. results physical indicated that dissolution tablet decreases all cases with time disintegration found within 15 minutes throughout course study while hardness demonstrated to be decline time. Kinetic treatment determine rate constants shelf lives dry suspension more stable than liquids showed three years which parallel their claimed expiry. Among tablets, brand A most among suspensions, longest stability. also using a software R-Gui (version 2.13) compared manually calculated results.

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