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-  2017 

Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs

Keywords: NAFDAC, ACT, Antimalarial Drug, Lumefantrine, Artemether, Amartem, Storage

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Abstract:

In this drug storage stability surveillance, we evaluated and compared the effects of different storage temperatures and ventilation conditions on the level of active pharmaceutical ingredient (API) of an ACT- based antimalarial (XYZ) drug formulation. The drug which contains artemether and lumefantrine is marketed by drug vendors in Lafia, Nasarawa state. From the analyses carried out, the concentration of lumefantrine (estimated with UV-Vis spectrophotometer) as well as Artemether (analyzed using HPLC) in the drug shows slightly different values which are statistically insignificant when investigated for the effects of storage temperatures and ventilation conditions. Drugs from pharmaceutical stores equipped with fan without cross ventilation (FNV), fan with inadequate ventilation (OCV), fan with cross ventilation (FCV) and fan with air conditioner (ACF) gave lumefantrine level of 494.30, 438.68, 472.48 and 488.68 mg respectively as against the label’s acclaimed 480 mg lumefantrine. The results for artemether includes: FNV (76.93), OCV (79.49), FCV (80.61) and ACF (73.55) milligrammes respectively as against 80 mg drug label claim. Reported values fell within the recommended (90%-120%) NAFDAC acceptable values for drug stability.

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