Stability Tests and Analytical Methods of Tacrolimus: A Review

Abstract

Tacrolimus is an immunosuppressive drug widely used in organ or tissue transplantation. Furthermore, its anti-inflammatory effects are employed in treatments for psoriasis, uveitis, and vernal keratoconjunctivitis. According to the structural characteristics of tacrolimus, different transformations can be occurred on the drug and produces degradation products. Thus, stability and stress tests have a key role in the quality of tacrolimus with a narrow therapeutic index. Up to now, different studies have been developed for the study of tacrolimus stability under different conditions, and the degradation products were detected by different analytical instruments. Therefore, in the current study, available studies about tacrolimus degradation were collected and categorized into five main parts including acidic hydrolysis, alkaline hydrolysis, thermal, oxidative, and photolytic for better survey. The known degradation products with their chemical structures were also discussed in this study. Moreover, the analytical methods that are applied for drug characterization during stability tests were explained.

Keywords

• tacrolimus
• immunosuppressive agent
• drug stability
• hydrolysis