Research Journal of Pharmaceutical Dosage Form and Technology

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Development and Validation of RP-HPLC Method for Estimation of Mycophenolate Mofetil in Bulk and Pharmaceutical Dosage Form


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1 Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi road, Guntur. A.P., India
     

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A simple, rapid, sensitive and precise high performance liquid chromatography (HPLC) method has been developed for the estimation of Mycophenolate mofetil in bulk and pharmaceutical dosage form. In this method RP-C18 column (250mmx4.6mm I.D and5μm particle size) with mobile phase consisting of acetonitrile and 0.02M phosphate buffer in the ratio of 50:50 v/v in isocratic mode was used. The detection wavelength is 230 nm and the flow rate is 1 ml/min. In the range of 10-60 μg/ml, the linearity of Mycophenolate mofetil shows a correlation coefficient of 0.999. 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 pharmaceutical dosage form. The method was fully validated according to ICH guidelines.

Keywords

Mycophenolate Mofetil, High Performance Liquid Chromatography, Validation.
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  • Development and Validation of RP-HPLC Method for Estimation of Mycophenolate Mofetil in Bulk and Pharmaceutical Dosage Form

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Authors

K. Rajendra Prasad
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi road, Guntur. A.P., India
S. Kathirvel
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi road, Guntur. A.P., India

Abstract


A simple, rapid, sensitive and precise high performance liquid chromatography (HPLC) method has been developed for the estimation of Mycophenolate mofetil in bulk and pharmaceutical dosage form. In this method RP-C18 column (250mmx4.6mm I.D and5μm particle size) with mobile phase consisting of acetonitrile and 0.02M phosphate buffer in the ratio of 50:50 v/v in isocratic mode was used. The detection wavelength is 230 nm and the flow rate is 1 ml/min. In the range of 10-60 μg/ml, the linearity of Mycophenolate mofetil shows a correlation coefficient of 0.999. 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 pharmaceutical dosage form. The method was fully validated according to ICH guidelines.

Keywords


Mycophenolate Mofetil, High Performance Liquid Chromatography, Validation.

References