METHOD: The effects of organic modifiers in mobile phase, protein precipitation agent to plasma sample ratio, and light on montelukast stability in unprocessed and processed human plasma, were evaluated. Validation was conducted in accordance with European Medicines Agency Guideline on bioanalytical method validation.
RESULTS: No interference peak was observed when acetonitrile was used as an organic modifier. Acetonitrile to plasma ratio of 4:1 produced clean plasma sample. Approximately 3 % of cis isomer was detected in unprocessed plasma samples while 21 % of cis isomer was detected in processed plasma samples after exposing to fluorescent light for 24h. The standard calibration curve was linear over 3.00-1200.00 ng/mL. All method validation parameters were within the acceptance criteria.
CONCLUSION: The validated method was successfully applied to a bioequivalence study of two montelukast formulations involving 24 healthy Malaysian volunteers. The light stability of a light sensitive drug in unprocessed and processed human plasma samples should be studied prior to pharmacokinetic/bioequivalence studies. Measures could then be taken to protect the analyte in human plasma from light degradation.
MATERIAL AND METHODS: The mice were divided randomly into a control group (aqua bidest and mercury acetate) and an experimental group for this purpose. The experimental mice group was given orally nano Ca supplementation in three dose groups (9 mg, 18 mg, and 27 mg/200 g animal body weight) once a day for 21 consecutive days. The mice are then given mercury acetate (1300 µg/200 g animal body weight intraperitoneally) on the 21st day. One hour after giving the nano Ca supplement, the mice's blood was taken. Liver and kidney were autopsied two days later to check quantitative and qualitative changes caused by mercury concentrations in liver and kidney histopathologies.
RESULTS: The results demonstrated the importance of nano Ca supplementation before mercury acetate induction, which has been shown to reduce necrotic depletion and hepatocyte degeneration.
CONCLUSION: Nano Ca supplementation has decreased the concentration of Hg in the blood of mice so that it can be used as a potential health supplement to detoxify mercury toxins.