BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENELIGLIPTIN, REMOGLIFLOZIN ETABONATE AND ITS APPLICATION TO PHARMACOKINETIC STUDIES IN RAT PLASMA BY USING LC-MS/MS

T. SATYADEV; BHARGAVI CHINTA; MANIKANTA RAKESH VEJJU; B. VICTOR PRADEEP SAGAR

doi:10.22159/ijap.2025v17i5.54860

Authors

T. SATYADEV Department of Chemistry, P B Siddhartha College of Arts and Science, Vijayawada, AP-520010, Inida
BHARGAVI CHINTA Department of Chemistry, Andhra Loyola College, Vijayawada-520008, Andhra Pradesh, India
MANIKANTA RAKESH VEJJU Department of Chemistry, Sir C R Reddy Autonomous College, Eluru, AP, India https://orcid.org/0009-0005-5539-657X
B. VICTOR PRADEEP SAGAR Department of Chemistry, Krishna University, Machilipatnam, AP, India https://orcid.org/0009-0005-6654-4339

DOI:

https://doi.org/10.22159/ijap.2025v17i5.54860

Keywords:

Teneligliptin, Remogliflozin etabonate, LC-MS/MS, USFDA guidelines, Rat plasma

Abstract

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.

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