A STUDY OF THERAPEUTIC RESPONSE AND ADVERSE EFFECTS OF INTRAVENOUS ERYTHROPOIETIN VERSUS SUBCUTANEOUS ERYTHROPOIETIN ON HEMODIALYSIS PATIENTS IN THE DEPARTMENT OF NEPHROLOGY OF OHRC

Objective: To study the efficacy of intravenous erythropoietin and subcutaneous erythropoietin in hemodialysis patients who have persistent anemia despite correction of iron therapy and to measure the outcomes in terms of raise in haemoglobin concentration and adverse events in both the groups.Methods: After ethical committee approval the current study was conducted at the Department of Hemodialysis of Owasi Hospital and Research Centre, Hyderabad a period of 6 mo duration. 60 patients undergoing hemodialysis were recruited into out study who had haemoglobin less than 10.0 despite corrected iron levels. Patients were divided into two groups for intravenous administration and subcutaneous administration of alpha erythropoietin. Patients were stratified into three sub-groups of mild, moderate and severe anaemia. Therapeutic response was recorded in the form of monthly hemoglobin and hemoatocrit. Of the 30 patients in the subcutaneous group, erythropoietin was given to 19 males and 11 females, while intravenous erythropoietin was administered to 17 males and 13 females in the other 30 patients.Results: The mean hemoglobin level in the subcutaneous group was 5.16 at the commencement of the study and in the intravenous group the mean hemoglobin was 5.0. In the subcutaneous group, the mean rise in the hemoglobin was rapidly achieved in 3 mo duration when compared to the intravenous group. Mean Systolic Blood pressure was higher in the intravenous group when compared to the subcutaneous group. Spillage of the drug was minimal in subcutaneous group when compared to the intravenous group.Conclusion: After correction of the iron deficiency, low dose of erythropoietin subcutaneously promised to maintain expected hemoglobin level above 10 g/dL with no adverse events compared to intravenous erythropoietin. Erythropoitin alpha at a dose of 4000 IU was enough to achieve the therapeutic target of Hemoglobin>10.0 by administering subcutaneously accelerated hypertension was less when compared to Intravenous erythropieitn post dialysis. Hence we recommend to use erythropoietin subcutaneously rather than intravenously

Novel microwell-based spectrophotometric assay for determination of atorvastatin calcium in its pharmaceutical formulations

The formation of a colored charge-transfer (CT) complex between atorvastatin calcium (ATR-Ca) as a n-electron donor and 2, 3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) as a π-electron acceptor was investigated, for the first time. The spectral characteristics of the CT complex have been described, and the reaction mechanism has been proved by computational molecular modeling. The reaction was employed in the development of a novel microwell-based spectrophotometric assay for determination of ATR-Ca in its pharmaceutical formulations. The proposed assay was carried out in 96-microwell plates. The absorbance of the colored-CT complex was measured at 460 nm by microwell-plate absorbance reader. The optimum conditions of the reaction and the analytical procedures of the assay were established. Under the optimum conditions, linear relationship with good correlation coefficient (0.9995) was found between the absorbance and the concentration of ATR-Ca in the range of 10-150 μg/well. The limits of detection and quantitation were 5.3 and 15.8 μg/well, respectively. No interference was observed from the additives that are present in the pharmaceutical formulation or from the drugs that are co-formulated with ATR-Ca in its combined formulations. The assay was successfully applied to the analysis of ATR-Ca in its pharmaceutical dosage forms with good accuracy and precision. The assay described herein has great practical value in the routine analysis of ATR-Ca in quality control laboratories, as it has high throughput property, consumes minimum volume of organic solvent thus it offers the reduction in the exposures of the analysts to the toxic effects of organic solvents, and reduction in the analysis cost by 50-fold. Although the proposed assay was validated for ATR-Ca, however, the same methodology could be used for any electron-donating analyte for which a CT reaction can be performed