Analytical Method Development and Validation of Marketed Product of Phenytoin Sodium by UV Spectrophotometer and Stress Degradation Studies

Abstract

A quick, accurate, and cost-effective UV spectroscopy method was developed to estimate the Phenytoin sodium in bulk, tablet dosage formulation using a solvent 0.1 N NaOH. Due to the high cost of antiepileptic drugs there is a need to develop a simple, accurate and cost effective method. UV-Spectrophotometric method was developed using 0.1 N NaOH as a solvent. According to ICH Q2(R1) requirements, the created technique was standardized in terms of validation parameters linearity, precision, accuracy, specificity, Limit of Detection (LOD), and Limit of Quantification (LOQ), like parameters like parameters were validated by using UV/visible spectroscopy technique and developed method was so simple, sensitive, precise, linear, accurate, robust, reproducible, and cost-effective. This newly established approach was effectively used to estimate phenytoin sodium in marketed formulation Eptoin. Phenytoin sodium API exhibits λmax at 216nm in the Beer’s range 2 to 10µg/ml So, Beer’s law was obeyed. The limit of detection (LOD) was found to be 0.564µg/ml and limit of quantification (LOQ) was found to be 1.71µg/ml. Recovery of phenytoin sodium in marketed formulation as Eptoin was observed in the range of 100 – 104%. The entire precision range was achieved at under 2% in accordance with ICH Q2(R1) standards. In both inter and intra-day examinations, it was found that the created UV method was precise, with % relative standard deviation varying from 0.27 to 0.46 and 0.26 to 0.46, respectively. The overall recovery percentage of Vinpocetine was found to range from 98.42 to 99.82%. LOQ and LOD were determined to assess the sensitivity of the method, yielding values of 0.4565 µg/ml and 0.1506 µg/ml, respectively. The estimation of Phenytoin sodium in its bulk form and commercial formulation was accomplished using the established method: A rapid, precise, and cost-effective UV spectrophotometric technique has been created to measure the concentration of Phenytoin sodium in bulk and tablet dosage forms.