ABSTRACT

Remogliflozin etabonate (REMO) and Teneligliptin (TNG) have been simultaneously estimated using reliable and accurate reverse phase liquid chromatographic technique in tablet dose form. The stationary phase used was BDS Hypersil C18 column (250 x 4.6 mm, 5?), while the mobile phase was a 75:25 (% v/v) Methanol: Potassium Dihydrogen Phosphate buffer combination. The analysis was conducted at 242 nm with a mobile phase flow rate of 1 mL/min. The method was linear in the concentration range of 100-200 ?g/mL for Remogliflozin Etabonate and 10-20 ?g/mL for Teneligliptin with correlation coefficient (r2) 0.998 and 0.996 respectively. Teneligliptin and Remogliflozin etabonate had retention times of 3.20 and 5.71 minutes, respectively. The limit of detection was 1.392 ?g/mL (REMO) and 0.288 ?g/mL (TNG). The limit of quantification was 4.22 ?g/mL (REMO) and 0.874 ?g/mL (TNG). It was discovered that the percent recoveries at 80%, 100%, and 120% were within the range of 98- 102%. According to the ICH Q2 (R2) guideline, the suggested method's linearity, accuracy, precision, and robustness all were verified. Studies on forced degradation were carried out to determine the potential degradation mechanism. With a noticeable difference in their retention time values, the deteriorated product peaks were clearly separated from the peak of the pure medication. In bothmedications, greatest degradation was seen with hydrogen peroxide during the stress assay with acid, base, peroxide, and temperature, suggesting the susceptibility of the molecule towards oxidative stress. Remogliflozin etabonate and Teneligliptin can be evaluated and stability samples can be analyzed using the established approach. Keywords: Remogliflozin etabonate, Teneligliptin, Liquid chromatography, Forced degradation, validation
Publication date: 01/09/2024

https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8280.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.9.8280