Stability indicating analytical method validation for determination of dissolution by HPLC for phenytoin sodium in phenytoin sodium capsules

Phenytoin, approved by the Food and Drug Administration in 1999 as a sedative for use in the intensive care unit, is a potent and highly selective α2-adrenoceptor agonist with significant sedative, analgesic and anxiolytic effects mostly used in the intensive care units. This article describes validation for the determination of Dissolution of Phenytoin Sodium in Phenytoin Sodium Capsules by using a high performance liquid chromatography. The high performance liquid chromatography resolution was achieved on an Hypersil BDS, 150 x 4.6mm, 5μm, column with an Isocratic elution at a flow rate of 1.0 mL/min using a mobile phase as Buffer and Acetonitrile in the ratio 60:40 v/v. The detection was performed by a photo diode array Detector. The method was validated for Linearity, Specificity, precision, Solution Stability and Accuracy. The method validation shows the linearity correlation 0.9999. The intra and inter-day precision are within acceptance criteria. Phenytoin sodium dissolution shows the stability of sample and standard solution upto 72 hours. The accuracy was within Limit (98 to 102 %). The overall mean recoveries of Phenytoin were 98.9. %

Author(s): Muralee Krishna, Meghana Nadre, Aniruddha V. Sherikar and Ranjith Reddy

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