Abstract
Development and validation of dissolution proceduresBhavesh Vaghela, Rajan Kayastha, Nayana Bhatt, Nimish Pathak, Dashrath Rathod
Highlights
IntroductionDronedarone, N- (2-Butyl-3-(p-(3-(dibutylamino) propoxy) benzoyl)-5-benzofuranyl) methane sulfonamide is a anti-arrhythmic agent (Fig 1)
Dronedarone, N- (2-Butyl-3-(p-(3-(dibutylamino) propoxy) benzoyl)-5-benzofuranyl) methane sulfonamide is a anti-arrhythmic agent (Fig 1).Chemically, dronedarone is a benzofuran derivative related to amiodarone, used is limited by toxicity due its high iodine content as well as by liver disease (Maryadele, 2013)
The present research work represents development of validated stability indicating P-HPLC method using milder stress conditions and study of degradation kinetics
Summary
Dronedarone, N- (2-Butyl-3-(p-(3-(dibutylamino) propoxy) benzoyl)-5-benzofuranyl) methane sulfonamide is a anti-arrhythmic agent (Fig 1). Dronedarone is a benzofuran derivative related to amiodarone, used is limited by toxicity due its high iodine content (pulmonary fibrosis, thyroid disease) as well as by liver disease (Maryadele, 2013). A survey of pertinent literature indicates that HPTLC (Dabhi et al, 2012), HPLC (Bhatt et al, 2013; Chhabra and Banerjee, 2013; Tondepu et al, 2012; Patel and Akhtar, 2012; Patel and Choudhury, 2012; Bolderman et al, 2009; Landge et al, 2013), RP-UPLC (Molleti et al, 2013) and Spectrophotometric (Pravalika et al, 2013) methods have been reported on quantification of dronedarone in pharmaceutical dosage forms and in biological samples. The present research work represents development of validated stability indicating P-HPLC method using milder stress conditions and study of degradation kinetics
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