Validation of an UPLC method for the determination of Pioglitazone Hydrochloride active substance in Pharmaceutical Dosage Forms

Year 2024, Volume: 28 Issue: 1, 385 - 395, 28.06.2025

Sinem Bilgiç Karaağaç , Dilek Bilgiç Alkaya , Serap Ayaz Seyhan , Buşra Nagihan Öztürk

Abstract

The present work reports an ultra-performance liquid chromatography (RP-UPLC) method for the quantitative determination of pioglitazone HCl (PGZ) in pharmaceutical dosage form. The chromatographic separation was performed on C18, BEH (50 mm x 2.1 mm, 1.7 μm) column using isocratic elution. The optimized mobile phase consists of phosphate buffer (pH:6) as a solvent-A and 55:45 v/v mixture of acetonitrile as solvent-B. Flow rate was 0.4 ml/min with UV detection at (λmax) 225 nm and the injection volume was set at 2 μL with retention time 1 min. The developed RP-UPLC method was validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, accuracy, linearity.

Keywords

Diabetes , Pioglitazone hydrochloride , UPLC , Validation , Pharmaceutical Dosage Form

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