World Journal of
Pharmaceutical and Life Sciences

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ANTIDIABETIC DRUGS (METFORMIN AND LINAGLIPTIN) IN TABLET DOSAGE FORM BY USING RP- HPLC METHOD

S. Srinivasa Rao*, M. Chandra Shekar, N. Nagaprasanna and T. Supriya

ABSTRACT

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Metformin and Linagliptin was successfully achieve dona THERMO, C18, 250cmx4.6mm, 5?m or equivalent in an isocratic mode utilizing KH2PO4: Methanol (65:35) at a flow rate of 1.0mL/min and eluate was monitored at 226nm, with a retention time of 3.132 and 3.728 minutes for Metformin and Linagliptin respectively. The method was validated and found to be linear in the drug concentration range of 50?g/ml to150 ?g/ml for Metformin and 50?g/ml to150 ?g/ml for Linagliptin. The values of the correlation coefficient were found to 0.999for Metformin and 1 for Linagliptin respectively. The LOD and LOQ for Metformin were found to be 1.909 and 6.362 respectively. The LOD and LOQ for Linagliptin were found to be 0.0349 and 0.1163 respectively. This method was found to be good percentage recovery for Metformin and Linagliptin were found to be 100 and 100 respectively indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.

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