Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF ARMODAFINIL IN BULK DRUG AND ITS PHARMACEUTICAL DOSAGE FORM

Ramakrishna Reddy Voggu*, Ravi Teja. Tumburu and M. Kishore

ABSTRACT

The objective of the present study was to develop and validate a novel RP-HPLC method for determination of Armodafinil in pharmaceutical dosage form. Chromatographic separation was conducted on Shimadzu-2010 with the quaternary pump, Symmetry-C8 column (4.6 mm I’d. X 150 mm, 5 μm particle sizes) and with photodiode array detector. Mobile phase consisted of Buffer and Methanol were mixed in the ratio of 40:60 v/v, was used at a flow rate of 1.0 ml/min and detection wavelength was set at 225 nm. The retention time for Armodafinil was found to be 3.20 min. The calibration was linear (r2=0.998) in the concentration range of 25 to 150 μg/ml. The limit of detection and the limit of quantitation were found to be 0.6812μg/ml and 1.9500μg/ml respectively. Recovery of Armodafinil in tablet formulation was observed in the range of 99.67- 101.80%. Percentage assay of Armodafinil was found to be 99.71% w/w. Thus the novel proposed method for Armodafinil was found to be feasible for the estimation of Armodafinil in bulk as well as a pharmaceutical dosage form.

Keywords: Armodafinil, RP-HPLC, Validation, ICH guidelines.