Abstract

Maged Alwan Noman, Mahmoud Mahyoob Alburyhi*, Abdalwali Ahmed Saif and Tawfeek A. A. Yahya

ABSTRACT

This study evaluated the quality of five commercially available of Atorvastatin Calcium tablets products marketed in Sana'a Yemen, with a view to determine their interchangeability in clinical practice. Survey of the assessed Atorvastatin brands was carried out in Sana'a city, Yemen. Drug products’ quality assessment included visual examination for their organoleptic properties; tests for weight variation, friability, hardness, disintegration time, dissolution profile and assay for Atorvastatin Content. Five marketed brands of Atorvastatin 20 mg tablets were collected from different pharmacies in Sana'a city. Quality parameters such as weight variation, hardness, thickness and friability were determined according to established protocols. In-vitro dissolution test, potency, disintegration time were also carried out. Dissolution and assay were determined by UV spectrophotometer at 241 nm. All the brands comply the requirements of Pharmacopoeia as they offer acceptable weight variation range hardness of all brands were within range “4-10 kg/cm” except Atorlip and no significant differences in disintegration times as they disintegrated within 5 minutes. In case of dissolution profile, all brands released more than 90% of drug in 60 minutes. We can conclude that there are all brands tablets it complies to (USP) and (BP) specifications in evaluation parameters. While in assay test all brands does not comply with the pharmacopoeia specifications, except Lipitor.