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A New Validated RP-HPLC Method for the Estimation of Mycophenolate Mofetil in Pure and Tablet Dosage Form


Affiliations
  • Shri Vishnu College of Pharmacy, Department of Pharmaceutical Analysis, Bhimavaram, India
  • Andhra University, Department of Pharmaceutical Analysis, A.U. College of Pharmaceutical Sciences, Visakhapatnam, India
 

A simple, rapid, sensitive and precise high performance liquid chromatographic (HPLC) method has been developed for the estimation of mycophenolate mofetil in bulk and tablet dosage form. In this method RP-C18 column (250mmx4.6mm I.D., 5im particle size) with mobile phase consisting of acetonitrile and 0.03M phosphate buffer in the ratio of 60:40 v/v in isocratic mode was used. The detection wavelength is 254 nm and the flow rate is 0.8 ml/min. In the range of 20-120μg/ml, the linearity of mycophenolate mofetil shows a correlation coefficient of 0.9995. The proposed method was validated by determining sensitivity, accuracy, precision and system suitability parameters. The mobile phase selected for the method is simple, fast, accurate and precise and hence can be applied for routine quality control analysis of mycophenolate mofetil in bulk and its tablet dosage form.

Keywords

HPLC, Mycophenolate Mofetil, Validation.
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  • A New Validated RP-HPLC Method for the Estimation of Mycophenolate Mofetil in Pure and Tablet Dosage Form

Abstract Views: 322  |  PDF Views: 167

Authors

Abstract


A simple, rapid, sensitive and precise high performance liquid chromatographic (HPLC) method has been developed for the estimation of mycophenolate mofetil in bulk and tablet dosage form. In this method RP-C18 column (250mmx4.6mm I.D., 5im particle size) with mobile phase consisting of acetonitrile and 0.03M phosphate buffer in the ratio of 60:40 v/v in isocratic mode was used. The detection wavelength is 254 nm and the flow rate is 0.8 ml/min. In the range of 20-120μg/ml, the linearity of mycophenolate mofetil shows a correlation coefficient of 0.9995. The proposed method was validated by determining sensitivity, accuracy, precision and system suitability parameters. The mobile phase selected for the method is simple, fast, accurate and precise and hence can be applied for routine quality control analysis of mycophenolate mofetil in bulk and its tablet dosage form.

Keywords


HPLC, Mycophenolate Mofetil, Validation.