ABSTRACT
Hypolipidemic drugs are widely used to lower the lipid profile and to prevent the primary and secondary risk of cardiovascular diseases. Among all the hypolipidemic agents, statins are the most prescribed drugs to treat hyperlipidemia. There are several statins’ molecules available in the market, but atorvastatin is the most widely prescribed. Therefore, it is essential that the drugs should have the appropriate amount of active pharmaceutical ingredient and meet the necessary physical properties. The aim of the present work was to evaluate the quality of different marketed products of Atorvastatin calcium tablets 10 mg available in Muscat, Oman with a view to determine their interchangeability in clinical practice. The Quality assessment included visual examination for their organoleptic properties; official and non-official quality control tests, dissolution profile, and invitro bioavailability assessment. Comparison of in vitro drug dissolution profile of all samples shows approximately more than 90% drug release within 60 min. In vitro dissolution, friability, disintegration, and hardness test, all were passed by investigated generic version of atorvastatin tablets sold in the Muscat, Oman. From these results it was concluded that all samples of Atorvastatin calcium tablets may be interchangeable with other in Oman. Keywords: Atorvastatin, Organoleptic properties, Invitro dissolution studies, Invitro bioavailability.
2024- l Journal of Pharmaceutical Quality Assurance
https://doi: 10.25258/ijpqa.15.4.1