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Accelerated Stability Studies of <i>Glinus lotoides</i> Tablets


Y Tesfa
K Asres
T Gebre-Mariam

Abstract



Accelerated stability studies were carried out on Glinus lotoides L. tablets for six months following the guidelines of International Conference on Harmonization (ICH) and European Agency for the Evaluation of Medicinal Products (EMEA) at 40 + 2 oC and 75 + 5% relative humidity (RH). A group of colour forming compounds was used as marker substances of Glinus lotoidesextract. Quantification of the active components
i.e., saponins of G. lotoideswas carried out by colourimetric analytical procedure. Physical properties of tablets, assay of colour forming compounds, and TLC profiles were used as parameters to study the stability. The results obtained indicated that optimized G. lotoidestablets were stable, as evidenced by the absence of significant changes in their physical properties, assay and TLC profiles.

Keywords: accelerated stability, Glinus lotoides tablets, ICH guidelines, EMEA guidelines, colourimetric assay

Ethiopian Pharmaceutical Journal Vol. 25 (1) 2007: pp. 43-50