Green high‐performance thin layer chromatography‐densitometric approach for tablet formulation containing remogliflozin etabonate and vildagliptin

摘要

Abstract A new high‐performance thin‐layer chromatography (HPTLC) method has been developed to analyze Vildagliptin (VLD) and Remogliflozin etabonate (RE) tablets. The procedure uses a mobile phase of methanol, ethyl acetate, toluene, and ammonia (1.5:7:1:0.5, by volume), a stationary phase of silica gel 60 F254 precoated TLC plates, and densitometry to gauge the amount of drug present. The method's linearity, accuracy, precision, and robustness were carefully evaluated. VLD and RE had Rf values of 0.46 and 0.64, respectively, with R2 values of 0.997, indicating good linearity over 10,000–50,000 ng/band for RE and 5000–25,000 ng/band for vildagliptin. Studies on forced deterioration were carried out to assess the probable degradation process. The resolution in the Rf values between the degradant and drug peaks was good. The study revealed that the drug was sensitive to hydrolysis and oxidative stress degradation and was transformed into the active Remogliflozin after the forced degradation tests. The Remogliflozin and RE bands were easily distinguishable. This method can be utilized for analyzing not only the tablet formulation of the drug but also stability samples and standard quality control samples. The Analytical Greenness Calculator methodology aided the greenness evaluation of the method.