TCH-040 Stability of Frozen Ceftazidime Solution in Polypropylene Syringes For Intravitreal Injection

Abstract

Background Ceftazidime is used for the treatment of endophthalmitis by intravitreal injection. For this emergency treatment, the syringes must be available immediately in the pharmacy. The stability at 2–8°C is limited and does not allow batch production. Purpose To study the stability of ready-to-use ceftazidime solution at 20 mg/mL in 0.9% sodium chloride in polypropylene syringes after storage at −20°C, to allow preparation in advance. Materials and Methods We used the High Performance Liquid Chromatography method published by Abdel Hamid ME et al,Farmaco 1998; 53: 132–138. The analytical conditions were: Column C18 5µ 200 × 4.6 mm. Mobile phase (ammonium acetate buffer 0.1 M pH 7.5/acetonitrile 90/10), flow rate: 1 mL/mn, wavelength: 256 nm. The HPLC method was validated according to ICH guidelines (linearity, repeatability, stability-indicating capability). Syringes were stored at −20°C and 4°C to compare with the literature data. Results Stability was defined according to ICH guideline Q1A: above 95% of the initial concentration of ceftazidime and concentration of degradation products less than 2%. After storage at 4°C, the ceftazidime concentration fell under 90% after 3 weeks and there was 65% of the initial concentration after 90 days. The ceftazidime solution at 20 mg/mL was stable for 3 months at −20°C with more than 96% of the initial concentration and degradation products under 0.8%. Conclusions Ceftazidime 20 mg/mL in 0.9% sodium chloride was stable for 3 months at −20°C. This allows batch preparation in advance and the immediate availability of the syringes to treat patients. No conflict of interest.