Saturday , 20 July 2019

Stability indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Metformin and Teneligliptin in Pharmaceutical Formulation

Ramesh Dhani*, V. Haribaskar, J. Priyanka
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, A.P, India

A B S T R A C T
A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin and Teneligliptin in pharmaceutical dosage form. Chromatogram was run through ODS2 C 18 (4.6 x 200mm, 10.0µm)column.   Mobile phase containing 50% Buffer and 50% Acetonitrile was pumped through column at a flow rate of 1.0ml/min. Temperature was maintained at ambient. Optimized wavelength for metformin  and teneligliptin was 240nm. The estimation of Metformin and Teneligliptin was done by RP-HPLC. The assay of Metformin and Teneligliptin was performed with tablets and the % assay was found to be 99.97 and 100.64 which shows that the method is useful for routine analysis.  The linearity of Metformin and Teneligliptin was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity.  The acceptance criteria of precision is RSD should be not more than 2.0% and the method show  precision 0.4 and 0.8 for Metformin and Teneligliptin which shows that the method is precise.  The acceptance criteria of intermediate precision is RSD should be not more than 2.0% and the method show  precision 0.1 and 0.7 for Metformin and Teneligliptin which shows that the method is repeatable when performed in different days also. The accuracy limit is the percentage recovery should be in the range of 97.0% – 103.0%.  The total recovery was found to be 99.86% and 99.96% for Metformin and Teneligliptin. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ is 3 and 10. The LOD and LOQ for Metformin was found to be 3.00 and 9.98 and LOD and LOQ for Teneligliptin was found to be 3.02 and 10.00.  The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions.
Keywords: Metformin, Teneligliptin, RP-HPLC      

Scroll To Top