RESUMEN
Detection of adverse drug reactions [ADRs] in hospitals provides an important measure of the burden of drug related morbidity on the healthcare system. Spontaneous reporting of ADRs is scare and several obstacles to such reporting have been identified formerly. This study aimed to determine the role of clinical pharmacy residents in ADR reporting within a hospital setting.Clinical pharmacy residents were trained to report all suspected ADRs through ADR-reporting yellow cards. The incidence, pattern, seriousness, and preventability of the reported ADRs were analyzed. During the period of 12 months, for 8559 patients, 202 ADR reports were received. The most frequently reported reactions were due to anti-infective agents [38.38%]. Rifampin accounted for the highest number of the reported ADRs among anti-infective agents. The gastro-intestinal system was the most frequently affected system [21.56%] of all reactions. Fifty four of the ADRs were reported as serious reactions. Eighteen of the ADRs were classified as preventable. Clinical pharmacy residents' involvement in the ADR reporting program could improve the ADR reporting system
RESUMEN
A gradient reversed-phase high performance liquid chromatography [HPLC] method was developed for the assay of cetrorelix acetate, a synthetic decapeptide with gonadotropin-releasing hormone [GnRH] antagonistic activity used in infertility treatment. The HPLC method, which is used to determine cetrorelix in bulk and pharmaceutical dosage forms, was validated per ICH guidelines. The chromatographic separation was achieved on a C18 reversed-phase column using acetonitrile, water and trifluoroacetic acid [TFA] as mobile phase and wavelength was set at 275 nm. The calibration curve was linear [r[2] = 0.999] over cetrorelix concentrations ranging from 62.50 to 12.50 micro g/mL [n = 6]. The limits of detection [LOD] and quantification [LOQ] were calculated from the peak-to-noise ratio as 15.6 and 62.5 micro g/mL, respectively. The method had an accuracy of > 97% and intra- and inter-day RSD of < 0.3% and < 1.6%, respectively and was validated with excellent specificity, sensitivity, and stability. The validated method was successfully applied for determination of cetrorelix in bulk and pharmaceutical dosage forms