Author: Kambham Venkateswarlu, Ardhgeri Rangareddy, Kanaka Narasimhaiah, Hemraj Sharma and Naga Mallikarjuna Raja Bandi
Publishing Date: 2017
Volume 30 Issue 1
The main objective of present study was to develop a RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product. The method was developed for Armodafinil estimation and base hydrolytic products were characterized. The separation was carried out on C18 column by using mobile phase as mixture of water and methanol (45:55%v/v). Eluents were detected at 220nm at 1ml/min. Stress studies were performed with milder conditions followed by stronger conditions so as to get sufficient degradation around 20%. A total of five degradation products were detected and separated from analyte. The linearity of the proposed method was investigated in the range of 20-120μg/ml for Armodafinil. The detection limit and quantification limit was found to be 0.01183μg/ml and 0.035μg/ml respectively. The precision % RSD was found to be less than 2% and the recovery was between 98-102%. Armodafinil was found to be more sensitive to the base hydrolysis and yielded its carboxylic acid as degradant. The developed method was stability indicating assay, suitable to quantify Armodafinil in presence of possible degradants. The drug was sensitive to acid, base & photolytic stress and resistant to thermal & oxidation.
KEYWORDS: Armodafinil, Stability indicating assay, RP-HPLC method, degradation studies.