Friday , 12 July 2024

RP-HPLC method for the Simultaneous estimation of Ezitimibe and Simvastatin in bulk and it’s tablet dosage form

C. Karuppasamy*1, Sanjay Kumar Jain2
1Safa College of Phrmacy, Kurnool, Andhra Pradesh, India
2Department of Pharmaceutical Analysis, Bundelkhand University, Jhansi, U.P, India

The present attempt was made to development and validation of new RP-HPLC method for the simultaneous estimation of Ezitimibe and Simuvastatin in bulk and tablet dosage form. The chromatographic separation was performed by Waters C 18 (4.6 x 250mm, 5.0mm) column and the mobile phase was consisting of Phosphate buffer: Acetonitrile in the ratio of 30:70.  The flow rate was maintained at 1.5 ml/min and UV detection of wavelength was observed at 225 nm. The linearity was found to be 10 µg/ml to 50µg/ml for both drugs with correlation coefficient was found to be 0.999.  The mean percentage recovery was found to be 100.50 % for Ezitimibe and 99.37% for Simuvastatin. All the validation parameters are present in within the limit. So, the developed method was can be applied to the quality control analysis of analytical laboratories for the simultaneous estimation of Ezitimibe and Simuvastatin.
Keywords: Ezitimibe, Simuvastatin, RP-HPLC, Mobile phase, Validation

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