Development and Validation of RP-HPLC method for determination of Modafinil in bulk and dosage form(3ò¬

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 Buffer:Acetonitrile in a ratio of 55:45 (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.Key Words: Method development; validation; Modafinil; Tablets; Hypersil C18 Column; RP-HPLC.DOI: http://dx.doi.org/10.3329/icpj.v1i4.10062International Current Pharmaceutical Journal 2012, 1(4): 77-80