Spectrophotometric methods for the estimation of mycophenolate mofetil |
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Authors: | S Verma H Gupta O Alam P Mullick N Siddiqui and S A Khan |
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Institution: | (1) Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic;(2) The Research Centre LN00B125, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic;(3) Bochemie Group, Herbacos-Bofarma Ltd, trossova 239, 530 02 Pardubice, Czech Republic; |
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Abstract: | An attempt was made to develop and validate a novel, simple, cost effective, accurate, and reproducible UV-spectrophotometric
method to estimate mycophenolate mofetil in bulk and pharmaceutical formulations. Mycophenolate mofetil was estimated at 250
nm in 0.1N hydrochloric acid (pH 1.2) and in acetate buffer (pH 4.5). Beer’s law was obeyed in the concentration range of
5–40 μg/ml in hydrochloric acid and in the acetate buffer medium. The methods were tested and validated for various parameters
according to ICH guidelines. The proposed methods were successfully applied for the determination of mycophenolate mofetil
in pharmaceutical formulations (tablets and capsules). The results demonstrate that the procedure is accurate, precise, and
reproducible (relative standard deviation <2%) while being simple, cheap, and less time-consuming, and hence can be suitably
applied for the estimation of mycophenolate mofetil in different dosage forms and for dissolution studies. |
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