1Research Scholar, Faculty of Pharmacy, Karpagam Academy of Higher Education, Coimbatore-641032, Tamil Nadu, India
2Professor, Faculty of Pharmacy, Karpagam Academy of Higher Education, Coimbatore-641032, Tamil Nadu, India
Received: 16th Dec, 2025; Revised: 8th Feb 2026; Accepted: 12th Feb, 2026; Available Online: 28th Feb, 2026
A Novel Robust Design of Experiments (DoE) based RPHPLC technique was established for quantifying pioglitazone and teneligliptin in dosage form. By using statistical models, a methodical and structured approach is used to determine the relationships between independent variables that affect one or more dependent variables. Using a quadratic model with 13 experimental runs, optimisation was done and using the "Central Composite Design" (CCD) response surface methodology. This led to analysis and optimisation of dependent variable's correlation with the independent factors. Retention time, tailing factor, and resolution are response variables, while mobile phase ratio, flow rate are the chosen input components. Graphical optimisation was carried out using 3-D surface plots, perturbation, and contour plots. A PDA-detector, an automated device injector, a binary solvent delivery pump, and an HPLC Agilent 1220 Infinity II were used in the development. An Agilent Inertsil ODS 3 (250mm x 4.6mm, 5μm) was used to achieve separation. Pioglitazone and teneligliptin were shown to have retention time of 5.794 and 8.764 minutes, respectively. Using mobile phase, acetonitrile and phosphate buffer pH 3 in a ratio of 60:40% at a flow rate of 1ml/min produced better peak resolution. The UV detection was set at 247nm, and injection volume was 9µl. Good precision, accuracy, and improved peak resolution were achieved when the method was validated based on ICH recommendations. Furthermore, assessment using AGREE and MoGAPI green metrics confirmed the method's sustainability and minimal environmental impact. The validated RP-HPLC method is well-suited for consistent quality evaluation of pioglitazone and teneligliptin in combined pharmaceutical products, making it reliable for routine analysis in quality control laboratories.
Keywords: AQBD; Agree; ICH guidelines; Method development; RPHPLC; Validation
How to cite this article: Devi Swapna PV and G. Saravanan, CCD-Based Quality by Design Strategy for RP-HPLC Method Development and Optimization for Quantifying Pioglitazone and Teneligliptin. Int J Drug Deliv Technol. 2026; 16(2): 236-250; DOI: 10.25258/ijddt.16.2.27
Source of support: Nil.
Conflict of interest: None