Phenytoin Case Study
Abstract
Phenytoin is generally an antiepileptic drug that is used to treat seizures and epilepsy. The influence of types of container (glass and plastic), amber or non-amber, and storage temperatures (4, 25 and 40°C) on the stability of 12 extemporaneously prepared Phenytoin oral suspension was evaluated. The concentration of Phenytoin oral suspension was evaluated using high performance liquid chromatography (HPLC), in which the retention time of Phenytoin was detected at 6.3 minutes. Phenytoin oral suspension was found to be stable up to two weeks, retaining minimal of 76.5% of Phenytoin. Degradation could have taken place as a lower concentration of Phenytoin (53.8 to 87.7%) was detected in week 4. Both inter- and intra-day validation results demonstrated consistently high precision and …show more content…
One hundred microliters of phenytoin oral suspension was withdrawn from each sample and diluted with the mobile phase at the ratio of 1:100. The samples were then centrifuged to remove any precipitation prior to HPLC analysis.
3.6 Sterility Test
Sterility test was carried out on day 28. Twenty microliters of phenytoin oral suspension was withdrawn from each sample and spread on the petri dish. All the petri dish were incubated in CO2 incubator at 37ºC for 24 hours. The growth of microorganisms was evaluated.
4.0 Results 4.1 High performance liquid chromatography method development for phenytoin Based on the chromatogram shown in Figure 4.1, the retention time for phenytoin was found to be approximately 6.3 minutes. A calibration curve in Figure 4.2 was plotted and the linear equation was Y = 5.917x+6.152 with the regression value R2=0.999. The accuracy and precision values for various concentration of phenytoin are shown in Table 4.1. The limit of detection value is 1µg/ml and limit of quantification value is
Phenytoin is generally an antiepileptic drug that is used to treat seizures and epilepsy. The influence of types of container (glass and plastic), amber or non-amber, and storage temperatures (4, 25 and 40°C) on the stability of 12 extemporaneously prepared Phenytoin oral suspension was evaluated. The concentration of Phenytoin oral suspension was evaluated using high performance liquid chromatography (HPLC), in which the retention time of Phenytoin was detected at 6.3 minutes. Phenytoin oral suspension was found to be stable up to two weeks, retaining minimal of 76.5% of Phenytoin. Degradation could have taken place as a lower concentration of Phenytoin (53.8 to 87.7%) was detected in week 4. Both inter- and intra-day validation results demonstrated consistently high precision and …show more content…
One hundred microliters of phenytoin oral suspension was withdrawn from each sample and diluted with the mobile phase at the ratio of 1:100. The samples were then centrifuged to remove any precipitation prior to HPLC analysis.
3.6 Sterility Test
Sterility test was carried out on day 28. Twenty microliters of phenytoin oral suspension was withdrawn from each sample and spread on the petri dish. All the petri dish were incubated in CO2 incubator at 37ºC for 24 hours. The growth of microorganisms was evaluated.
4.0 Results 4.1 High performance liquid chromatography method development for phenytoin Based on the chromatogram shown in Figure 4.1, the retention time for phenytoin was found to be approximately 6.3 minutes. A calibration curve in Figure 4.2 was plotted and the linear equation was Y = 5.917x+6.152 with the regression value R2=0.999. The accuracy and precision values for various concentration of phenytoin are shown in Table 4.1. The limit of detection value is 1µg/ml and limit of quantification value is