HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY (HPTLC) METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF REMOGLIFLOZIN ETABONATE AND VILDAGLIPTIN IN BULK AND ITS TABLET FORMULATION

Abstract

Objective: Within the scope of this investigation, an HPTLC technique for measuring the concentrations of Remogliflozin etabonate (REMO) and Vildagliptin (VIL) in a commercial product named REMO-V, which contains 100 mg of REMO and 50 mg of Vildagliptin (VIL), was developed.

Methods: It was necessary to evaluate the new approach for linearity, precision, specificity, and robustness in order to ensure that it operated properly. The chromatograms were created using a mobile phase containing Chloroform as follows: The concentrations of toluene, methanol, and n-butanol (4.5:4:1:0.5, v/v) were measured on a pre-coated TLC aluminum pre-coated plate (60F 254), and the absorbance at 233 nm was used to determine the amount of each component present. It was necessary to conduct forced degradation testing on bulk medicinal material in order to demonstrate the new method's capacity to demonstrate how stable and specific it is.

Results: The Rf values for Remogliflozin etabonate (0.63), Vildagliptin (0.75), and Remogliflozin etabonate (0.63), respectively, were 0.63 and 0.75. On the REMO side, the linearity of the technique was found to be between 20 and 60 g/band; on the VIL side, it was found to be between 10 and 30 g/band. Having R2 values of 0.9939 for both REMO and VIL, it is clear that there is significant linearity in the way they interact with one another. These are the lower limits of detection and quantification for REMO, which were 0.09 for VIL and 0.38 for REMO, respectively, when compared to the upper limits of detection and quantification for VIL. The lower detection and quantification limits for VIL are also the same as for other pathogens. RSD was less than 2 percent in this study. Thus, the approach was shown to be accurate and exact for both interday and intraday accuracy, indicating that it is reliable. The amount of REMO or VIL that might be recovered is as follows: 98.7 percent to 101.27 percent, and 97.37 percent to 100.83 percent were the results.

Conclusion: It was discovered that the method for determining Remogliflozin and Vildagliptin was easy, accurate, and stable in both its pure form and its tablet dose form and that it could be used to both (REMO-V, Glenmark, Ltd)