A novel LC-MS/MS technique estimates pharmacokinetics of teneligliptin and remogliflozin etabonate, ensuring accuracy and compliance with USFDA standards.
Objective: An easy, quick, precise, active and reproducible LC-MS/MS (Liquid Chromatography Tandem Mass Spectrometry) technique was developed for the simultaneous estimation of Teneligliptin and Remogliflozin etabonate in rat plasma using Ertugliflozin as internal standard (IS). Methods: An elaborate protein precipitation extraction technique used Ertugliflozin as internal standard for Remogliflozin Etabonate and Teneligliptin. The two compounds were separated on a Zorbax SB C18 column (250x4.6 mm, 5µ), an isocratic program utilizing 0.1% perchloric acid and acetonitrile (ACN) at a ratio of 70:30 as mobile phases to achieve a separation in 10 min. Results: In the teneligliptin range of 0.5–20 ng/ml and the remogliflozin etabonate range of 5-200 ng/ml, the calibration curve was linear. At various QC (Quality Control) concentration levels, teneligliptin and remogliflozin etabonate recovered with accuracy and precision of 95.41%, 95.41%, 97.29%, and 95.23%, 96.08%, 98.10%, respectively. The findings of the matrix effect were within the permissible range. Teneligliptin and Remogliflozin etabonate were studied using an electrospray ionisation source at mass analysis ion pairs 427.5839 → 118.0474, 523.5967→88.6473, and 437.8882→140.7849, respectively, for ertugliflozin. Conclusion: When used successfully for the examination of rat pharmacokinetic studies, the application indicates that all system appropriateness, specificity, linearity, and accuracy characteristics are in excellent compliance with USFDA (United States of Food and Drug Administration) requirements.
No takes yet. Share an insight, caveat, or question.
Satyadev et al. (2025) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: