Optimization and Validation of Stability-Indicating RP-HPLC Method for Teneligliptin and Pioglitazone using Response Surface Methodology

Saidatri  Arige; Lakshmana Rao  Atmakuri; Vijaya Kumar  Ghanta; Ramesh  Alluri; Satya Venkata Sakuntala  Mamidi; Uday Kumar  Thokala

doi:10.5530/ctbp.2026.2s.16

Authors

Saidatri Arige V. V. Institute of Pharmaceutical Sciences, Gudlavalleru – 521 356, Andhra Pradesh
Lakshmana Rao Atmakuri V. V. Institute of Pharmaceutical Sciences, Gudlavalleru – 521 356, Andhra Pradesh
Vijaya Kumar Ghanta KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada – 520 010, Andhra Pradesh
Ramesh Alluri Vishnu Institute of Pharmaceutical Education & Research, Narsapur – 502 313, Telangana
Satya Venkata Sakuntala Mamidi Department of Pharmacy, Government Polytechnic for Women, Kakinada – 533 003, Andhra Pradesh
Uday Kumar Thokala V. V. Institute of Pharmaceutical Sciences, Gudlavalleru – 521 356, Andhra Pradesh

DOI:

https://doi.org/10.5530/ctbp.2026.2s.16

Keywords:

Teneligliptin, Pioglitazone, HPLC, Response Surface Methodology, Validation, Forced Degradation Studies

Abstract

The research work discloses establishment & thorough validation of method for stability-assessing RP-HPLC system designed for concurrent assessment of Teneligliptin & Pioglitazone in both bulk drug and tablet formulations. Response Surface Methodology was applied to optimize key chromatographic variables, including acetonitrile concentration in mobile phase (ranging from 70% to 80%), rate of flow (0.9 to 1.1mL/minute), & temperature of column (30°C to 40°C), in order to meet predefined critical quality attributes (CQAs) as peak retention time, resolution, & tailing factor. HPLC system of Waters Alliance make, operating with UV detector set to 229nm, was employed for separation process. Optimized composition of mobile phase was combination of 71.9:29.1 (v/v) acetonitrile & HSA buffer, with buffer pH attuned to 2.5 with orthophosphoric acid. Established retention times for Teneligliptin & Pioglitazone were 5.615 and 2.258 minutes, correspondingly. Stress testing confirmed that technique effectively separated APIs from their degradation products, validating its stabilityindicating nature. Method validation, conducted in harmony with ICH guidelines, confirmed strong linearity, high precision, accuracy, and robustness. Recovery values were within 98-102% range, with no observable interference from excipients or degradation products. Furthermore, low LOD and LOQ demonstrated method’s suitability for sensitive & routine pharmaceutical analysis. In summary, RP-HPLC method developed and optimized through RSM offers robust, cost-effective, and reproducible analytical approach, well-suited for quality control & routine assessment of Teneligliptin & Pioglitazone in commercial pharmaceutical preparations.