DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METOPROLOL AND AMLODIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

*D. Neelima Rizwana Begum and Dr. A. Yasodha

ABSTRACT

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Metoprolol and Amlodipine in bulk and pharmaceutical formulations. Separation of Metoprolol and Amlodipine was successfully achieved on a Agilent zorbax XDB C18 (150 mm×4.6mm,5μ)or equivalenting an isocratic mode utilizing Potassium dihydrogen phosphate (pH-4.8): Methanol (40:60) v/v at a flow rate of 1.0mL/min and eluate was monitored at 235nm,with are Retention time of 1.694 and 3.234 minutes for Metoprolol and Amlodipine. The developed method was validated and the response was found to be linear in the drug concentration range of 50μg/mL to 150 μg/mL for Metoprolol and 50μg/Ml to 150μg/mL for Amlodipine. The values of the slope and the correlation coefficient were found to be y=26615x+ 43142 and 0.999 for Metoprolol and y=5560x-1243 and 0.999 for Amlodipine respectively. The LOD and LOQ for Metoprolol were found to be 1.36,4.12 respectively. The LOD and LOQ for Amlodipine were found to be 1.0, 3.0 respectively. This method was found to be good percentage recovery for Metoprolol and Amlodipine were found to be 100.00 and 100.31 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.

Keywords: Metoprolol, Amlodipine, RP?HPLC, Simultaneous estimation.