Validation of routine analytical method for injectable cyclosporine preparation control using HPLC-FIA assay.

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.

[Trisomy 21 and cancers]. / Trisomie 21 et cancers.

Patients with trisomy 21, still called Down's syndrome (DS), present a particular tumoral profile compared to the general population with an increased incidence of leukaemia in the childhood and a low risk of solid cancer in the adulthood. DS children indeed present a 50-fold risk of developing a leukaemia compared to age-matched non-trisomic children and most of them develop a specific myelodysplasic disorder called transient myelodysplasic disorder. In spite of the low incidence of solid tumors, some are very rare as breast cancer, nephroblastoma, neuroblastoma and medulloblastoma, whereas the others remain more frequent as retinoblastoma, lymphoma and gonadal and extragonadal germ cell tumours. In this review, we present possible mechanisms which can favour, or on the contrary repress the formation and progression of tumours in DS patients, which are related to gene effect dosage of oncogenes or tumour repressors on chromosome 21, tumour angiogenesis, apoptosis and epithelial cell-stroma interactions.

Leukemia in Patients with Klinefelter Syndrome: A Report of Two Cases.

Klinefelter syndrome (KS) is a chromosome abnormality characterized by a 47, XXY karyotype associated with hypogonadism and infertility. We present two cases of leukemia in patients with KS. The first patient presented with acute promyelocytic leukemia. He relapsed after the end of treatment. The second patient was diagnosed with chronic myeloid leukemia. Treatment with imatinib failed and the patient presented with myeloid blast crisis.