Analytical Method Development and Validation by RP-HPLC for the Simultaneous Estimation of Linagliptin and Metformin in Bulk and Combined Tablet Dosage Form

G. Varun Kumar*, V. Pavan kumar, M. Gobinath, V. Hari Baskar, Ramesh Dhani, Y. Vijitha
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Muthukur, SPSR Nellore, A.P, India

A B S T R A C T
A new simple accurate and suitable reverse phase high performance liquid chromatographic method was developed for the determination of Metformin and Linagliptin in bulk and tablet dosage form. The separation was eluted on a Zodiac C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of mixed phosphate buffer 6.5 and acetonitrile in a ratio of 50:50 v/v at a flow rate of 1.0ml/min. The detection was made at 248 nm. The retention times were 2.080.1min for Metformin and 5.730.1min for Linagliptin. Calibration curve was linear over the concentration range of 125-750μg/ml for Metformin and 0.625 – 3.750 μg/ml for Linagliptin. The propose method was validated as per the ICH guidelines parameters like Linearity, specificity, precision, accuracy, robustness and ruggedness. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.
Keywords: Method development and validation, Metformin Linagliptin, Tablets, RPHPLC