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 223nm. Linearity range was found to be 2-18 ?g/ml. The correlation coefficient was found to be 0.999. The limit of detection and limit of quantification were found to be 0.010µg/ml and 0.032?g /ml respectively. The degradation behavior of Modafinil was carried out as per the standard procedures and guidelines. 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. Keywords: Modafinil, UV –Spectroscopy, Validation, ICH guidelines, Assay
Publication date: 01/07/2022

https://ijbpas.com/pdf/2022/July/MS_IJBPAS_2022_6207.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.7.6207