Development and validation of a reversed-phase HPLC method for the simultaneous determination of alogliptin and pioglitazone in combined tablet dosage form
Department of Chemistry, College of Science, University of Kirkuk, Kirkuk, Iraq.
Research Article
International Journal of Chemical and Pharmaceutical Research Updates, 2026, 07(01), 019–032
Article DOI: 10.53430/ijcpru.2026.7.1.0041
Publication history:
Received on 28 May 2026; revised on 04 July 2026; accepted on 06 July 2026
Abstract:
A simple, accurate and robust reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of alogliptin (ALO) and pioglitazone (PIO) in a combined tablet dosage form. The analytes were separated on a C18 column (250 × 4.6 mm, 5 µm) using acetonitrile:25 mM phosphate buffer pH 4.2 (55:45, v/v) as the mobile phase at a flow rate of 1.0 mL/min. Detection was carried out at 228 nm with an injection volume of 20 µL and a total run time of 10 min. Under the optimized conditions, ALO and PIO were eluted at 2.834 and 6.418 min, respectively, with resolution greater than 10. The method was linear over 5-50 µg/mL for ALO and 6-60 µg/mL for PIO, with regression equations y = 80500.0x + 24500.6 (R² = 0.9991) and y = 61200.0x + 35000.3 (R² = 0.9994), respectively. The limits of detection were 0.34 and 0.42 µg/mL, while the limits of quantification were 1.03 and 1.27 µg/mL for ALO and PIO, respectively. The assay results were 98.88% for ALO and 101.03% for PIO. Accuracy, precision, solution stability, robustness and specificity were within acceptable validation limits, although small experimental deviations were observed in replicate response, recovery and assay values. The proposed method is suitable for routine quality-control analysis of the selected binary antidiabetic combination.
Keywords:
Alogliptin; Pioglitazone; RP-HPLC; Simultaneous Estimation; Method Validation; Tablet Assay.
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