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Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE DETERMINATION OF MODAFINIL IN BULK AND TABLET DOSAGE FORMS

M. Lakshmi Surekha*, M. Murali Krishna and Nazia Malik

ABSTRACT

The validated reverse phase liquid chromatographic method developed and validated for the quantification of Modafinil in bulk drug and in Pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a PhenomenaxLunaC18 (ODS) column (150 X 4.6 mm i.d., particle size 5). The mobile phase consisting of phosphate buffer pH 3.0: Acetonitrile (60:40, v/v). An isocratic elution was achieved at a flow rate of 1 ml/ min at ambient temperature. The detection was carried out at 225nm using Shimadzu UV-Visible detector SpD-10AVP. The retention time of Modafinil was found to be 3.2 min. The calibration curve was linear in the concentration range of 5-30g/ ml (r2═ 0.9999). The limit of detection and the limit of quantification were found to be 0.580531 g/ml and 1.75918g/ml respectively. The amount of Modafinil present in the formulation was found to be 99.79  0.8075. The method was validated statistically using the SD, %RSD and SE and the values were found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 101.10±1.635%. So, the proposed method was found to be simple, specific, linear, and rugged. Hence it can be applied for routine analysis of Modafinil in the Pharmaceutical formulation.

Keywords: Modafinil, RP-HPLC Method, Validation, System suitability tests.


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