European Journal of Biomedical and Pharmaceutical Sciences

ANALYTICAL METHOD VALIDATION REPORT FOR ASSAY OF METFORMIN HCL, EMPAGLIFLOZIN&LINAGLIPTIN BY RP-HPLC

Dange Shital Shrirang* and Dr. Kalyankar Tukaram Mohanrao

ABSTRACT

A New method was established for simultaneous estimation of Metformin, Empagliflozin, Linagliptin by RP-HPLC method. Chromatographic separations were carried using Thermo Hypersil, C18(4.6 x 150mm, 5m) column with a mobile phase composition of 40% KH2PO4 buffer 60% Methanol have been delivered at a flow rate of 1ml/min and the detection was carried out using waters HPLC auto sampler, separation module 2695 with PDA detector 2996 at wavelength 224 nm.The retention time for Metformin, Empagliflozin, Linagliptin were 3.399, 5.586 and 6.439 minute respectively. The correlation coefficient values in linearity were found to be 0.999 and concentration range 600-1800 μg/ml for Metformin, 2-10 μg/ml for Empagliflozin and 1-5 μg/ml for Linagliptin respectively. For accuracy the total recovery was found to be 99.12 %, 100.48 % and 100.75 % for Metformin, Empagliflozin and Linagliptin respectively. The force degradation studies were performed for the dosage form and the results are within the limits. The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Metformin, Empagliflozin, Linagliptin in pharmaceutical dosage form.

Keywords: Metformin, Empagliflozin, Linagliptin, RP?HPLC, Simultaneous estimation.