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Background Amiodarone has been widely dispensed as capsules prepared in the pharmacy department for paediatric patients. A stability study was performed with these capsules to determine their expiry date. However the European Pharmacopoeia High Performance Liquid Chromatography (HPLC) method was not performed because of a worldwide shortage of acetonitrile at the beginning of our stability study. Purpose The purpose was to develop a HPLC assay of amiodarone capsules that did not use acetonitrile. Materials and methods The authors developed the assay on a chromatographic system consisting of a Spectra-Physics Analytical HPLC chain. The column used was a C18 (120Ä, 250 mm x 4.6 mm, 5 µm). The mobile phase was 0.01 M phosphate buffer pH 2.30 + methanol (17/83 v/v) with a flow rate of 1 ml/min. The sample injection volume was 20 µL. The analysis time was 15 min. The validation study was performed according to ICH. The chromatography parameters (retention time, number of theoretical plates, tailing factor, capacity factor) were calculated to study the system suitability test. Specificity (interference from mannitol, excipient), linearity, precision (repeatability and intermediate precision) and accuracy checks were performed. Results In chromatographic conditions, amiodarone retention time was 7.47 minutes. The capacity factor and the number of theoretical plates were respectively 1.34 and 5,313. The tailing factor did not exceed 1.5. No interference from mannitol could be observed at 242 nm. Within the assay range, amiodarone concentration was linearly related to absorbance at 242 nm. The repeatability and the intermediate precision were demonstrated because relative SD was less than 2%. The method is accurate because the 100% value was within the confidence limits. Conclusions The method developed in this study has the advantage of being simple, precise, accurate and convenient. This method is applicable for qualitative and quantitative amiodarone capsules. The results are accurate and precise and confirmed by statistical parameters.

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.

aeruginosa (ATCCVR 9027TM), Candida albicans (ATCCVR 10231TM), Aspergillus brasiliensis (ATCCVR 16404TM) and Staphylococcus aureus (ATCCVR 6538TM). To perform the growth assay, trypticase soy agar (TSA) were used for P aeruginosa and S aureus, and sabouraud glucose agar (SAB) for C albicans and A brasiliensis. The test was performed by taking a 1:1000 dilution of 1 g of topical resorcinol in a 0.1% Tween 80 and phosphate buffered saline solution and adding 100 mL of a suspension equivalent to 1×103 cfu/mL of every ATCC strain, which were inoculated in TSA or SAB. All tests were done in duplicate and medium lectures were made in 48 hours. Results The ability of ATCC strains to growth in resorcinol formulation was confirmed under the study conditions. There was mean growth of 17×104 cfu/mL for S aureus and 11×104 cfu/mL for P aeruginosa in TSA. For A brasiliensis and C albicans, 1×104 cfu/mL and 2×104 cfu/mL were detected, respectively. Conclusion and relevance The presented method shows a simplified way to test the microbiological viability of 15% topical resorcinol for quality control.