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ICH Q3B (R2) (2006) Impurities in New Drug Substances and Products (Step 4). International Conference on Harmonization, 86-95.

has been cited by the following article:

  • TITLE: Effect of Acid, Base and Time on Different Brands of Glimepiride

    AUTHORS: Safila Naveed, Hina Qamar, Wardha Jawaid, Urooj Bokhari

    KEYWORDS: Glimepiride, Degradation Studies, Assay, USP

    JOURNAL NAME: Open Access Library Journal, Vol.1 No.5, August 19, 2014

    ABSTRACT: The objective of this study is to develop the degradation studies of different brands of glimepiride available in market. Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stability-indicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drugs. Glimepiride is a medium- to long-acting sulfonylurea antidiabetic drug as it is the most prescribed oral antihyper glycaemic agent indicated to treat type 2 diabetes mellitus. Its mode of action is to increase insulin production by the pancreas. This is not used for type 1 diabetes because in type 1 diabetes the pancreas is not able to produce insulin. Glimepiride was subjected to different stress conditions as per (ICH) International Conference on Harmonization guidelines. Distilled water was used as solvents and the amount of drug was calculated after degradation by taking absorbance at 200 nm. According to the assay limit of USP specified that the content should not be less than 95% and not more than 105% of labelled amount. On basic pH brand A, and E showed degradation after the addition of 0.1 N base while other brands degraded as base has no impact on glimepiride concentration. On addition of 0.1 N HCl only brand E showed heavy degradation. After 48 hours the absorbance of all brands are different compared with initial absorbance which shows degradation of all brands.