Analytical Method Development and Validation of Modafinil in Pure and Tablet Dosage Form by UV Spectroscopy

Abstract

The present study deals with development and validation of a simple, rapid, accurate, economical and reproducible UV-Spectrophotometric method was developed for estimation of Modafinil in pure form and tablet dosage form. Modafinil was estimated at 260nm. Linearity range was found to be 2-10 µg/ml. The correlation coefficient was found to be 0.99987. The molar absorptivity was found to be 10409 L mol/cm. The proposed method Sandell’s sensitivity was found to be 0.02778 µg cm-2/0.001AU. The limit of detection and limit of quantification were found to be 4.67981and14.18125 µg /ml respectively. The degradation behavior of Modafinil was carried out as per the standard procedures and guidelines. Forced acid hydrolytic degradation, alkali degradation and oxidative degradation of Modafinil was performed in bulk and solid oral formulation using 1N Hydrochloric acid and 0.1M Sodium hydroxide at room temperature in different time intervals. The resulting solutions were analyzed for content by UV spectrophotometry at the maximum absorption of 260 nm. The assay value of Modafinil in bulk and formulation was calculated at different time intervals for intraday and interday experiments. The proposed method was successfully applied for the determination of Modafinil in bulk and Pharmaceutical formulations (Tablets). The results were demonstrated, that the procedure is accurate, precise and reproducible (relative standard deviation < 2%), Modafinil was found to degrade extensively under alkali conditions. Modafinil has to be stored under such condition where the possibility of alkali hydrolysis does not arise.