Introduction:

Zoledronic acid is an inhibitor of bone resorption used in the treatment of Paget's disease, the prevention of glucocorticoid-induced osteoporosis, osteoporosis in postmenopausal women and in men.

Aim:

To evaluate the stability of a new lyophilized injection of zoledronic acid 5 mg through the quality parameters.

Methods:

An HPLC method with UV detector was validated for the finished product and the chemical stability of the formulation was determined through the presence of degradation products and the concentration of zoledronic acid in the finished product. In addition, the organoleptic characteristics, pH, sterility and bacterial endotoxins, particles in injectables and totality and transparency of solutions were measured.

Results:

The chromatographic method was satisfactory for its use in the evaluation of the finished product. 3 batches of the lyophilized 5 mg zoledronic acid injection were made which met the quality limits established during 6 months (accelerated stability) and up to 24 months (shelf life).