Dissolution method development and validation for simultaneous determination of metformin and teneligliptin in pharmaceutical tablets Jagtap Kanchan*, Patel Sejalben, Shah Ujashkumar Department of Pharmaceutical Science, Nootan Pharmacy College, Sankalchand Patel University, Visnagar-384315, Gujarat, India *Corresponding Author E-mail: mandlikkanchan24@gmail.com
Online Published on 10 October, 2023. 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. Top Keywords Stability-indicating RP-HPLC, Metformin, Teneligliptin, ICH guidelines, Dissolution and validation. Top |