Abstract
We have developed and validated an inexpensive, selective, simple, and precise HPLC-RP dissolution method for estimating the concentration of Metformin and Teneligliptin in combination dosage form. This experimental analysis was performed on a reverse phase high performance high-performance liquid chromatography, (RP-HPLC) column (250mm x 4.6mm, 5µm) by using Mobile phase Acetonitrile and Potassium Dihydrogen Phosphate with concentration 0.05 M and buffer with pH-7.0 at a flow rate of 1.0ml/min and the detected at wavelength 225nm. In line with ICH guidelines, the linearity of the analytical method was discovered to be in the range of 7.0 to 21.00g/ml for Metformin. The linearity of the method for Teneligliptin was 22.5-67.5g/ml. Metformin and Teneligliptin had correlation coefficients greater than 0.990. The relative standard deviation value for system precision and method was less than 2.0%. All statistical data proves validity of the method and can be used for routine analysis of pharmaceutical dosage form.
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