Development and validation of HPLC method to determination of Methotrexate in children oncologic patients.

OBJECTIVE: The acute lymphocytic leukemia is a hematopoietic cancer that occurs predominantly in children. Methotrexate is one of the most useful drugs in cancer chemotherapy. The aim of the study was to develop and validate the methodology of high performance liquid chromatography (HPLC) with ultraviolet detection for methotrexate dosage and to determine its concentration in plasma samples from children with leukemia. PATIENTS AND METHODS: The study included patients from the outpatient care of pediatric oncology at the Faculty of Medicine of ABC carriers in treatment of leukemia. The study was conducted in chromatographic model Agilent 1100 with UV detector at 302 nm and by the method of ELISA microplate reader capable of reading absorbance at 450 nm. RESULTS: We obtained satisfactory results of selectivity, accuracy, linearity, limit of quantification (LOQ), limit of detection (LOD), precision and robustness and apply the basic criteria for validation as RE No. 899, of May 29, 2003 Guide validation of analytical and bioanalytical National Agency Health Surveillance (ANVISA). CONCLUSIONS: We conclude that results for linearity/concentration range, precision, robustness, limit of quantification and detection limits are within the acceptance criteria defined by ANVISA and that the developed analytical method is valid and feasible to be used as a tool in monitoring therapy of methotrexate.

Anti-inflammatory and analgesic actions of etoricoxib (an NSAID) combined with misoprostol.

This study has evaluated the anti-inflammatory and analgesic responses of etoricoxib, a selective COX-2 non-steroidal anti-inflammatory drug combined with misoprostol in pre-clinical assays. Groups of animals (mice and rats) were subjected to rat's paw edema induced by carrageenan, and writhing and formalin tests in mice. Treatment with etoricoxib, misoprostol, and etoricoxib combined with misoprostol inhibited the inflammation process by 35 %, 30 %, and 61 %, respectively in the rat paw edema induced by carrageenan with the greatest effects being obtained in the group treated with etoricoxib combined to misoprostol. In the writhing test, etoricoxib inhibited the number of writhes by 33 %, and by 27 % when combined with misoprostol. In the first phase of the formalin test (nociceptive), treatment with the combination of etoricoxib and misoprostol inhibited significantly this process by 45 %, while in the second phase (inflammatory), etoricoxib inhibited this by 97 %, the etoricoxib + misoprostol inhibited this by 78 %, respectively. The responses observed have demonstrated that the combination of etoricoxib and misoprostol increased the anti-inflammatory response, but it did not show effect in the peripheral analgesic response.