ANALYITCAL METHOD DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY FOR THE DETERMINATION OF MODAFINIL IN BULK AND PHARMACEUTICAL DOSAGE FORMS
DOI:
https://doi.org/10.22159/ajpcr.2016.v9i5.13178Abstract
Objective: To development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) for the determination of modafinil in bulk and pharmaceutical dosage forms.
Methods: A simple, precise, rapid, and accurate RP-HPLC method was developed for the estimation of modafinil in bulk and pharmaceutical dosage
forms. Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size) with a mobile phase consisting of methanol:water 70:30 V/V was used. The flow rate
1.0 ml/min and the effluents were monitored at 260 nm. The retention time and recovery time was 12 minutes. The detector response was linear in
the concentration of 10-50 μg/ml. The respective linear regression equation being Y=452.1x+65237. The limit of detection and limit of quantification
were 4.547 and 1.377 mcg, respectively. The method was validated by determining its accuracy, precision, and system suitability.
Result: The objective of the present work is to develop simple, precise, and reliable HPLC method for the analysis of modafinil in bulk and
pharmaceutical dosage forms. This is achieved using the most commonly employed Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size) column
detection at 260 nm. The present method was validated according to ICH guidelines.
Conclusion: In this study, a simple, fast and reliable HPLC method was developed and validated for the determination of modafinil in pharmaceutical
formulations.
Keywords: Modafinil, Reversed-phase high-performance liquid chromatography, Estimation, ICH guidelines, Tablets.
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