Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Metformin.
| Autor: | Vetapalem R; Acharya Nagarjuna University, Department of Biotechnology, Nagarjuna Nagar, India., Yejella RP; University College of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Andhra University, Visakhapatnam, India., Atmakuri LR; Vallabhaneni Venkatadri Institute of Pharmaceutical Sciences, Department of Pharmaceutical Analysis, Gudlavalleru, India. |
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| Jazyk: | angličtina |
| Zdroj: | Turkish journal of pharmaceutical sciences [Turk J Pharm Sci] 2020 Apr; Vol. 17 (2), pp. 141-147. Date of Electronic Publication: 2020 Apr 24. |
| DOI: | 10.4274/tjps.galenos.2018.16768 |
| Abstrakt: | Objectives: The main objective of the present work is to develop a simple, precise, specific and stability method indicating reverse phase high performance liquid chromatography method for simultaneous estimation of teneligliptin and metformin in bulk and tablet dosage form. Materials and Methods: The analysis was performed with a Kromasil C18 column (250×4.6 mm, 5 μm) at 30°C using buffer: acetonitrile: methanol (65:25:10, v/v/v) as mobile phase. The detection was carried out with a flow rate of 1.0 mL/min at 254 nm. Results: The retention time of teneligliptin and metformin was 2.842 min and 2.017 min, respectively. The linearity range was 5-30 μg/mL for teneligliptin and 125-750 μg/mL for metformin. The forced degradation studies were performed as per the guidelines of the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use under acidic, alkaline, oxidative, thermal, photostability, and neutral conditions. Conclusion: This method was successfully validated for all the parameters and could detect the the correct amounts of active drug substance in formulations that are available in the market. This developed method in the present study could be successfully employed for the simultaneous estimation of teneligliptin and metformin in bulk and tablet dosage form. Competing Interests: Conflicts of interest: No conflict of interest was declared by the authors. The authors alone are responsible for the content and writing of this article. (©Copyright 2020 Turk J Pharm Sci, Published by Galenos Publishing House.) |
| Databáze: | MEDLINE |
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