Stability Indicating Method Development and Validation of Teneligliptin and Pioglitazone using UHPLC in Pure and Pharmaceutical Formulation.

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Sameer Narayan Godase, Mahesh Hari Kolhe, Shubham Balasaheb Mhaske, Kavita Vitthalrao Dhamak, Rohit Jaysing Bhor


Introduction: Teneligliptin and Pioglitazone in pharmaceutical combined form can use to treat and control the type 2 diabetes mellitus. Objective: The objective is to develop a novel, easy, fast, accurate UHPLC method and validate it as per the ICH guidelines. This method aims to determine both Teneligliptin and Pioglitazone in pure and pharmaceutical formulation. Method: Separation of analyte was carried out using an Agilent C18 (2.5μm; 4.6 x 100 mm ID) column connected to a PDA detector. The moving phase consists of methanol and TEA in (60:40) with flow rate 0.9 ml per minute. Analytes were detected at 241 nm wavelength. Result: Under optimized condition the retention time was found to be 2.382 for Teneligliptin and 3.315 for Pioglitazone with sharp peak. The linearity of a method was found to be 2-10µg/ml and 1.5-7.5µg/ml for Teneligliptin and Pioglitazone respectively having a coefficient of correlation (R2) 0.999. Teneligliptin's Limit of Quantification and Limit of Detection were determined to be 0.0843 and 0.255 and 0.0084 and 0.025 for Pioglitazone. The procedure is accurate, as demonstrated by the founded good percent recovery. Conclusion: The method was developed and validated as per guidelines of International Conference on Harmonization. Forced degradation study of both the drugs was done in controlled acidic, basic, peroxide and hydrolysis condition. The develop method shows its suitability for the regular quantitative analysis of both Teneligliptin and Pioglitazone in their pure form or in pharmaceutical formulation. This application of method serves for the purpose of quality control.

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