A validated stability indicating RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product | [Pakistan Journal of Pharmaceutical Sciences • 2017]

Author(s):

1. Kambham Venkateswarlu: Department of Pharmaceutics, JNTUA- Oil Technological and Pharmaceutical Research Institute, Ananthapuramu, Andhra Pradesh,India

2. Ardhgeri Rangareddy: Department of Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research,Ananthapuramu, Andhra Pradesh,India

3. Kanaka Narasimhaiah: Department of Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research,Ananthapuramu, Andhra Pradesh,India

4. Hemraj Sharma: Department of Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research,Ananthapuramu, Andhra Pradesh,India

5. Naga Mallikarjuna Raja Bandi: Department of Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research,Ananthapuramu, Andhra Pradesh,India

Abstract:

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.

Page(s): 23-28

DOI: DOI not available

Published: Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 30, Issue: 1, Year: 2017

Keywords:

Stability indicating assay , Armodafinil , RPHPLC method , degradation studies

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