ABSTRACT

Several spectrophotometric and HPLC methods have been reported for the determination of Teneligliptin in drugs and pharmaceutical dosage forms. In the present study, a new, sensitive, suitable, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of Pioglitazone in bulk drug and tablet formulation. In the RP-HPLC method, a mobile phase consisting of Methanol and Water (75:25 % v/v) was used at a flow rate of 1.0 ml/min. The analysis was performed on an HPLC system equipped with a UV detector, using Openlab EZchrome software and a Kromasil C18 column (250 mm x 4.6 mm, 5 ?m). Detection was carried out at 258 nm, yielding a suitable retention time of 3.60 minutes for Teneligliptin. The method was validated through various parameters including filter study, solution stability, specificity, linearity, accuracy, precision (repeatability and intermediate precision), limit of detection, limit of quantification, and robustness. The developed method proved to be simple and precise for the assay of Pioglitazone in bulk drug and tablet formulation. It requires regular reagents and is less time-consuming, making it suitable for routine analysis in the pharmaceutical industry for both bulk drug and marketed products of Teneligliptin and Pioglitazone. Keywords: Teneligliptin, Pioglitazone, RP-HPLC, Method Development, Validation, Bulk Drug, Tablet Dosage Form
Publication date: 01/12/2025

https://ijbpas.com/pdf/2025/December/MS_IJBPAS_2025_9613.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.12.9613