Volume No. :   5

Issue No. :  4

Year :  2015

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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



Address:   Suman Pattanayak*, A. Alekhya Prasanna, Ch. Kiranmayi, K. Padmalatha
Department of Pharmaceutical Analysis and Quality Assurance. Vijaya Institute of Pharmaceutical Sciences for Women. NH-5, Enikepadu. Vijayawada - 521 108
*Corresponding Author
DOI No: 10.5958/2231-5675.2015.00033.2

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 ?max 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.
Cite:
Suman Pattanayak, A. Alekhya Prasanna, Ch. Kiranmayi, K. Padmalatha. Analytical UV Spectroscopic Method Development and Validation for the Estimation of Mycophenolate Mofetil. Asian J. Pharm. Ana. 5(4): 2015; 209-213.
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