Spectrophotometric methods for the estimation of mycophenolate mofetil
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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.
Keywordsmycophenolate mofetil spectrophotometric method validation
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- 2.F. Birnbaum, S. Mayweg, A. Reis, D. Bahringer, B. Seitz, K. Engelmann, E. M. Messmer, T. Reinhard, Eye, 24, online, doi: 10.1038/eye.2008.402
- 7.The European Agency for the Evaluation of Medicinal Products. ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95, 1996.Google Scholar
- 8.United States Pharmacopoeia, Validation of Compendial Methods, 26th ed., Pharmacopoeial Convention Inc., Rockville, MD, 2003, pp. 2439-2442.Google Scholar
- 9.S. Bolton, Pharmaceutical Statistics: practical and clinical application, 3rd ed., Marcel Dekker, New York, 1997, pp 216–264.Google Scholar
- 10.J.C. Miller, J.N. Miller, Statistics for Analytical Chemistry, 2nd ed., Wiley, New York, 1984, pp 83–117.Google Scholar