Development and Validation of RP-HPLC method for determination of Modafinil in bulk and dosage form.

ABSTRACT

A reverse phase high performance liquid chromatographic method was developed for the determination of Modafinil in bulk and dosage form. The separation was effective on a Hypersil ODS C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of BufferAcetonitrile in a ratio of 5545 (v/v) at a flow rate of 1.0ml/min. The detection was made at 220nm. The retention time of modafinil was found to be 4.80±0.06 min. Calibration curve was linear over the concentration range of 20-120μg/ml of modafinil. The proposed method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid and thus found to be suitable for the quantitative analysis of modafi-nil in the bulk and dosage form.