RP-HPLC METHOD FOR DETERMINATION OF ANTI-DIABETIC DRUG LIRAGLUTIDE IN BULK AND TABLET FORMULATION

RP-HPLC method for determination of anti-diabetic drug Liraglutide in bulk and tablet formulation has been developed and validated. A RP-HPLC method was performed on Agilent Zorbax Eclipse XDB C18(100mm×4.6mm, 3.5μm) column using PHP Buffer(10mM): MeOH: ACN 60:20:20%V/V (pH 3.8 Adjusted with 0.1% Ortho-phosphoric acid), as a mobile phase at a flow rate of 1.5ml/min and analytes were monitored at 245nm. The retention time for Liraglutide was found to be 2.66min. The peak obtained was symmetrical with tailing factor less than 2 and theoretical plates more than 2000. The linearity was found in the concentration range 10-60μg/ml for Liraglutide. LOD and LOQ was found to be 0.85μg/ml and 2.60μg/ml. for Liraglutide. The percentage mean recovery at three different levels (80%,100%120%) for Liraglutide was found to be 100.4 -105.37%w/w. The percentage assay of Liraglutide in dosage form was found to be 99.1-99.5%w/w. The method was validated in accordance with ICH guidelines Q2 (R1) and was found to be Specific, Accurate, Precise, Robust and can be successfully applied for routine analysis of Liraglutide in bulk and pharmaceutical dosage form. The developed method has been found suitable for routine analysis of Liraglutide in bulk and tablet formulation.