title: An ultraviolet-spectrophotometric method for the determination of glimepiride in solid dosage forms.
abstract: BACKGROUND
  Considering the cost of acquiring a liquid chromatographic instrument in underdeveloped economies, the rising incidence of diabetes mellitus, the need to evaluate the quality performance of glimepiride generics, and the need for less toxic processes, this research is an imperative.
  
  
  METHODS
  The method was validated for linearity, recovery accuracy, intra- and inter-day precision, specificity in the presence of excipients, and inter-day stability under laboratory conditions. Student's t test at the 95% confidence limit was used for statistics.
  
  
  RESULTS
  Using 96% ethanol as solvent, a less toxic and cost-effective spectrophotometric method for the determination of glimepiride in solid dosage forms was developed and validated. The results of the validated parameters showed a λ(max) of 231 nm, linearity range of 0.5-22 μg/mL, precision with relative SD of <1.0%, recovery accuracy of 100.8%, regression equation of y = 45.741x + 0.0202, R(2) = 0.999, limit of detection of 0.35 μg/mL, and negligible interference from common excipients and colorants. The method was found to be accurate at the 95% confidence limit compared with the standard liquid chromatographic method with comparable reproducibility when used to assay the formulated products Amaryl(®) (sanofi-aventis, Paris, France) and Mepyril(®) (May & Baker Nigeria PLC, Ikeja, Nigeria). The results obtained for the validated parameters were within allowable limits.
  
  
  CONCLUSIONS
  This method is recommended for routine quality control analysis.
authors.affiliation: Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development, Abuja, Nigeria. eriarieafieroho@yahoo.com
authors.forename: Ozadheoghene E
authors.initials: OE
authors.lastname: Afieroho
authors.forename: Ogbonna
authors.initials: O
authors.lastname: Okorie
authors.forename: Tochukwu J N
authors.initials: TJ
authors.lastname: Okonkwo
mesh_terms: D017408:Guidelines as Topic; D007004:Hypoglycemic Agents / Q000032:analysis*; D007390:International Agencies; D057230:Limit of Detection; D011786:Quality Control; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013453:Sulfonylurea Compounds / Q000032:analysis*; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000592:standards
chemical_list: D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D013607:Tablets; C057619:glimepiride