ABSTRACT
Aim
To develop and validate simple, accurate, precise, sensitive and robust Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) method for simultaneous estimation of metformin and teneligliptin in bulk and their pharmaceutical formulation by using Quality by Design (QbD) approach.
Materials and Methods
The factor screening studies were performed using 2 level 4 factor (16 run) full factorial design. C18 Gracesmart column (150×4.6 mm, 5 μ) was saturated with mobile phase acetate buffer pH 4: acetonitrile (56.4: 43.6 v/v). Mobile phase was pumped at flow rate 1 mL/min. Both the drugs metformin and teneligliptin detected by diode array detector at wavelength 250 nm.
Results
Retention time for metformin and teneligliptin were found to be 1.983 min and 3.263 min respectively. Metformin and teneligliptin show linear response in concentration range 50-300 μg/mL and 2-12 μg/mL respectively. % Recovery for metformin and teneligliptin was found to be 100.15%-101.43% and 98.76%-99.48% respectively. In precision study % relative standard deviation was found less than 2 for metformin and teneligliptin. Limit of Detection (LOD) for metformin and teneligliptin was found to be 1.281 μg/ mL and 0.464 μg/mL respectively. Limit of Quantification (LOQ) for metformin and teneligliptin was found to be 3.881 μg/mL and 1.407 μg/mL respectively.
Conclusion
The proposed method was found to be accurate, precise, sensitive and robust. As a result, it might be successfully employed for the routine analysis of metformin and teneligliptin in bulk and their pharmaceutical dosage forms.