ABSTRACT

A simple, selective, precise, and accurate chromatographic methods, namely High-performance thin- layer chromatography (HPTLC), were developed and validated for the simultaneous determination of Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate. The developed HPTLC method was used for the separation and quantitation of the studied drugs on silica gel 60F254 TLC plates (20 cm × 10 cm) and a mobile phase consisting of methanol, ethyl acetate, and chloroform (7:2:1 v/v), chromatographic separation was accomplished. The CAMAG Linomat 5 applicator was used for the spotting, and a microliter syringe was used. The detection wavelength was 226 nm. The design space was created and process parameters such as the solvent front, chamber saturation period, and mobile phase proportion were optimized using the quality by design methodology. Well-resolved symmetric peaks were obtained using this designed chromatographic technique. Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate were eluted at Rf 0.65 and 0.25, respectively. The ICH Q2 (R1) guideline was followed in the validation of this procedure. With r2=0.9996 and 0.9999, respectively, the approach demonstrated linearity in the range of 2-10 ?g per spot for Remogliflozin Etabonate and 0.2-1 ?g per spot for Teneligliptin Hydrobromide Hydrate. The label claim pertaining to the sample recoveries indicated that there was no influence from formulation ingredients throughout the estimate process. The stressed materials were analyzed using the described approach, and forced degradation investigations were conducted. Keywords: Remogliflozin Etabonate, Teneligliptin, Stability, Method, HPTLC
Publication date: 01/11/2024

https://ijbpas.com/pdf/2024/November/MS_IJBPAS_2024_8468.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.11.8468