Simple cost effective Method Development for the estimation of combined Anti-diabetic drugs in Marketed Formulation

Abstract

Metformin and Teneligliptin is a combination of two antidiabetic medicines: Metformin and Teneligliptin. Metformin is an antidiabetic medication (biguanide). It works by lowering glucose production in the liver, delaying glucose absorption from intestines and increasing the body's sensitivity to insulin. Teneligliptin is a dipeptidyl peptidase-4 inhibitor which works by increasing the release of insulin from pancreas and decreasing the hormones that raise blood sugar levels. This reduces both fasting and postmeal sugar levels. Together, they provide better control of blood sugar. The separation was achieved on Thermo C18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using Acetonitrile: Water in the ratio of 80:20v/v. The mobile phase was filtered through 0.45μ filter paper to remove particulate matter and then degassed by sonication. Flow rate employed for analysis was 1.0 ml/min. The total chromatographic analysis time per sample was about 20min with eluting at retention time of about 3.458±0.001min and 5.125±0.002 for metformin and Teneligliptin respectively. The method was validated for accuracy, precision, specificity, linearity and sensitivity. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The developed and validated method was successfully applied for the quantitative analysis of metformin and Teneligliptin tablet formulation. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of metformin and Teneligliptin in marketed formulation.