Quality Assessment of Brands and Generic in Atorvastatin Tablets Available in Iraq-thi-Qar

Abstract

Hypolipidemic agents have been shown to be helpful in the primary and secondary prevention of cardiovascular disease. Statins are frequently administered to treat hyperlipidemia. Although there are many statins on the market today, atorvastatin is the one that is most frequently recommended. The medications must meet the required physical qualities and contain the right quantity of active medicinal components. The primary goal of the study was to assess the value of several brands of atorvastatin calcium tablets sold in Iraq.Methods: In this study, the in vitro dissolving test, disintegration, friability, and hardness tests of the innovator product coded as (AT-1) and the generic brands (coded as AT-2) of atorvastatin tablets 20 mg available in Iraq were assessed. Drug analysis was done using a spectrophotometric technique. At a 240 nm wavelength, atorvastatin was found. The researched products released more than 90% of the atorvastatin in 30 minutes, per the findings of the dissolving testing. In under 30 minutes, the brands AT-1 and AT-2 showed a release of atorvastatin of over 95% and 86%, respectively. Our research revealed that the generic brand AT-2 and the innovator atorvastatin (AT-1) were of high pharmaceutical grade. In vitro dissolution, friability, disintegration, and hardness tests required by the pharmacopoeia were all passed by generic and innovator of atorvastatin tablets sold in the Iraqi market. Therefore, it was concluded that these generics might be utilized interchangeably by focusing on their in vitro release characteristics.