An optimization through experimental design approach for simultaneous quantification of Remogliflozin and Teneligliptin by RP-UFLC

Abstract

The combination of teneligliptin (TEN) with remogliflozin etabonate (REM) is the latest FDC approved for the treatment of type-2 diabetes. There is no QBD optimized UFLC method reported with short runtime for quantification of TEN and REM. Hence this research work aimed to find a new way to quantify a novel antidiabetic combination of TEN and REM using RP-UFLC technique with possible minimum run time, optimized with QBD. The method was executed using the Agilent Eclipse XDB C-18 column (150 x 4.6 mm; 5 μm), with the mobile phase comprising of buffer and acetonitrile (41:59) at a flow rate of 2.2 mL per minute and determination has been carried out at 230 nm. The retention time for TEN and REM was found at 0.770 and 1.465 minute correspondingly with runtime only 2 min. The method's effectiveness has been validated using ICH guideline for LOD, LOQ, linearity, precision, accuracy, robustness and forced degradation. In the proposed study, TEN and REM were successfully separated with very short run time of only 2 minutes. The results of validation for proposed UFLC method revealed the accuracy, specificity and forced degradation of the method. Furthermore, determination of TEN and REM from formulations showed the correctness of the method. The method is novel, easy to use, fast, precise and accurate and it can be used in QC laboratories for regular studies on API and dosages.