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Analytical UV Spectroscopic Method Development and Validation for the Estimation of Mycophenolate Mofetil


Affiliations
1 Department of Pharmaceutical Analysis and Quality Assurance. Vijaya Institute of Pharmaceutical Sciences for Women. NH-5, Enikepadu. Vijayawada - 521 108, India
     

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A simple, precise, accurate UV-spectroscopic method was developed and validated for the determination of Mycophenolate Mofetil in bulk and dosage form using solvents like methanol for dissolving the drug and acetate buffer of pH-3.5 for dilutions. At the λmax of 250nm, it was proved linear in the range 10- 50 μg/ml, and exhibit good correlation coefficient (R2 =0.995) and excellent mean recovery (99.990-100.014). The developed method was validated for accuracy, precision, robustness, ruggedness according to ICH guidelines. All these parameters showed adaptability of the method for the quality control analysis of Mycophenolate Mofetil in bulk and in marketed formulation.

Keywords

Mycophenolate Mofetil, UV-Spectroscopy, Acetate Buffer, Validation.
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  • Analytical UV Spectroscopic Method Development and Validation for the Estimation of Mycophenolate Mofetil

Abstract Views: 186  |  PDF Views: 3

Authors

A Suman Pattanayak
Department of Pharmaceutical Analysis and Quality Assurance. Vijaya Institute of Pharmaceutical Sciences for Women. NH-5, Enikepadu. Vijayawada - 521 108, India
A. Alekhya Prasanna
Department of Pharmaceutical Analysis and Quality Assurance. Vijaya Institute of Pharmaceutical Sciences for Women. NH-5, Enikepadu. Vijayawada - 521 108, India
Kiranmayi
Department of Pharmaceutical Analysis and Quality Assurance. Vijaya Institute of Pharmaceutical Sciences for Women. NH-5, Enikepadu. Vijayawada - 521 108, India
K. Padmalatha
Department of Pharmaceutical Analysis and Quality Assurance. Vijaya Institute of Pharmaceutical Sciences for Women. NH-5, Enikepadu. Vijayawada - 521 108, India

Abstract


A simple, precise, accurate UV-spectroscopic method was developed and validated for the determination of Mycophenolate Mofetil in bulk and dosage form using solvents like methanol for dissolving the drug and acetate buffer of pH-3.5 for dilutions. At the λmax of 250nm, it was proved linear in the range 10- 50 μg/ml, and exhibit good correlation coefficient (R2 =0.995) and excellent mean recovery (99.990-100.014). The developed method was validated for accuracy, precision, robustness, ruggedness according to ICH guidelines. All these parameters showed adaptability of the method for the quality control analysis of Mycophenolate Mofetil in bulk and in marketed formulation.

Keywords


Mycophenolate Mofetil, UV-Spectroscopy, Acetate Buffer, Validation.