Dissolution method development and validation by uplc fordetermination of phenytoin sodium in phenytoin sodium capsules

Ranjith Reddy ., Muralee Krishna., Aniruddha V. Sherikar and Pushpendra Sharma

A rapid, accurate and precise Ultra Performance Liquid Chromatographic (UPLC) method was developed for generating an exhaustive In-Vitro Dissolution profiles of phenytoin sodium capsules in an Immediate Release formulations. The method has been validated. The method employs Waters UPLC system on Acquity BEH C18, 100 x 2.1mm, 1.7µm column with a flow rate of 0.3 mL/min using a mobile phase of 50-50% of Buffer and Acetonitrile. The UPLC was equipped with a uv-visisble Detector and the measurements were taken at 229nm. The immediate release formulations label claim were 300mg, 100mg, 50mg and 25mg for which the injection volume was appropriately selected. The total runtime for each injection was 2mins only with the retention time of the phenytoin peak at about 1.4mins.The method was validated for Linearity, Specificity, precision, Solution Stability and Accuracy. The method validation shows the linearity correlation 0.999.

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DOI: http://dx.doi.org/10.24327/ijcar.2017.6716.1001
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