ABSTRACT
OBJECTIVE: The aim of this study is to validate a new HPLC-FIA method for routine analytical control of cyclosporine injectable preparations and to evaluate the routine analytical control with this technic. MATERIAL AND METHODS: Cyclosporine dosage was carried out by the HPLC-FIA method. The column was replaced by a PEEK (polyetheretherketone) loop tubing. The mobile phase consisted of ultrapure water. The injection volume was 1µL with a flow rate of 1mL/min. All determinations were performed at 35°C. The detection was carried out at 210nm. The accuracy profile method was used to validate the HPLC-FIA assay of cyclosporine. Routine control was applied for each cyclosporine preparation using the HPLC-FIA developed method. An acceptance limit of ±10% of the theoretical concentration has been set for the conformity of the preparation. RESULTS: The accuracy profile shows the validity of our method for the dosage of cyclosporine in the concentration range studied (0.5-2.5mg/mL) with good linearity (correlation coefficient>0.999), high precision (the relative standard deviation [RSD] values, for both repeatability and intermediate precision, were<3%) and acceptable trueness (the relative biases were found<2%). In our study, 220 injectable cyclosporine preparations were analyzed: 85% were compliant. All analyzes were conform after a second standardized homogenization of 10 shakes. CONCLUSIONS: The proposed HPLC-FIA method is a reliable, fast, simple, precise method that can be easily used for the routine quality control of cyclosporine injectable preparations.
Subject(s)
Cyclosporine , Chromatography, High Pressure Liquid , Quality Control , Reproducibility of ResultsABSTRACT
We present the case of an actinomycotic mycetoma of the foot due to Actinomycetes viscosus. It evolved for nine years on the foot of a 26-year-old patient from a rural environment: Douar Inezgane (city in southern Morocco). Bacteriological study of the skin and grains confirmed the diagnosis. It showed positive bacilli on direct examination and on Gram staining and in positive culture. Histological study showed a polymorphous granulomatous inflammation without signs of malignancy with actinomycotic grains. Then we retained the diagnosis of primary cutaneous actinomycosis without visceral locations. The treatment was based on antibiotics: penicillin G by intravenous infusion for five weeks, relayed orally by amoxicillin associated with trimethoprim-sulfamethoxazole for long periods. After six months of treatment, we observed a favorable outcome with reduction of the swelling, nodules, lymphadenopathy, fistula's number and extension of time of issue of grains. The current follow up is 15 months. The primary cutaneous actinomycosis is still relevant in Morocco.
