QbD Guided Central Composite Design Optimized RP-HPLC Method for Teneligliptin Assay in Dosage Forms

Srinivasa Rao  Yarguntla; Vasudha  Dadi; Bhagavan Rajesh Babu  Koppisetty; Sridevi Ranjitha  Karanam; Anusha  Gandi; Mounica  Peela

doi:10.5530/ctbp.2026.2s.4

Authors

Srinivasa Rao Yarguntla Department of Pharmaceutical analysis, Vignan Institute of Pharmaceutical Technology (Autonomous), Visakhapatnam-530046, Andhra Pradesh
Vasudha Dadi Department of Pharmaceutical analysis, Vignan Institute of Pharmaceutical Technology (Autonomous), Visakhapatnam-530046, Andhra Pradesh
Bhagavan Rajesh Babu Koppisetty Department of Pharmaceutical analysis, Vignan Institute of Pharmaceutical Technology (Autonomous), Visakhapatnam-530046, Andhra Pradesh
Sridevi Ranjitha Karanam Department of Pharmaceutical analysis, Vignan Institute of Pharmaceutical Technology (Autonomous), Visakhapatnam-530046, Andhra Pradesh
Anusha Gandi Department of Pharmaceutical analysis, Vignan Institute of Pharmaceutical Technology (Autonomous), Visakhapatnam-530046, Andhra Pradesh
Mounica Peela Department of Pharmaceutical analysis, Vignan Institute of Pharmaceutical Technology (Autonomous), Visakhapatnam-530046, Andhra Pradesh

DOI:

https://doi.org/10.5530/ctbp.2026.2s.4

Keywords:

Teneligliptin, RP-HPLC, Stability indicating, Forced degradation

Abstract

In this study, we present a robust and reliable RP-HPLC method designed to accurately assess the content of teneligliptin in marketed formulations. The process of method development included refining chromatographic conditions to effectively quantify Teneligliptin within formulations. The column used for optimal separation had a C18 composition and dimensions of (250 mm, 4.6 mm, 5 μm). The mobile phase consists of acetonitrile and 1-Octane sulfonic acid sodium salt buffer in a ratio of 62.5:37.5 v/v. at 0.90 mL/min. Detection occurred at 244 nm, with teneligliptin showing a retention time of 5.056 minutes. Validation investigations affirmed the method's appropriateness for quantification, showcasing exceptional linearity, precision, accuracy, and specificity. In summary, this RP-HPLC methodology presents a valuable resource for the routine assessment of teneligliptin formulations, guaranteeing the maintenance of product quality and integrity.