Abstract

The objective of present work was to develop and validate a simple, accurate, precise HPLC method for the estimation of Metformin and Linagliptin. The chromatographic separation was achieved on a Hypersil BDSC18column (4.6x250 mm, 5μmparticlesize).Different mobile phase systems in different proportions were tried. For HPLC method a mobile phase consisting of KH2Po4 and acetonitrile(40:60) produced symmetric peak shape with good resolution for both the drugs. Next, the drugs were chromatographed under different flow rates from which a flow rate of 1.0 ml/min was selected. The retention times of Metformin and Linagliptin were found to be 2.464 min and 4.011 min, respectively.The proposed method was found to have excellent linearity in the concentration range of 100-600 and 0.5-3 μg/ml with correlation coefficient r2=0.999 and 0.999 for Metformin and Linagliptin repectively. The method was validated for linearity, precision, LOD, LOQ and robustness. The proposed method optimized and validated as per ICH guidelines

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