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. 2020 Apr;17(2):141-147.
doi: 10.4274/tjps.galenos.2018.16768. Epub 2020 Apr 24.

Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Metformin

Rajani Vetapalem  1 , Rajendra Prasad Yejella  2 , Lakshmana Rao Atmakuri  3
Affiliations

Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Teneligliptin and Metformin

Rajani Vetapalem et al. Turk J Pharm Sci. 2020 Apr.

Abstract

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.

Keywords: RP-HPLC; Teneligliptin; metformin; stability studies; validation.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Chemical structure of TEN TEN: Teneligliptin
Figure 2
Figure 2
Chemical structure of MET MET: Metformin
Figure 3
Figure 3
Chromatogram showing resolved peaks of TEN and MET TEN: Teneligliptin, MET: Metformin
Figure 4
Figure 4
Linearity plot of TEN TEN: Teneligliptin
Figure 5
Figure 5
Linearity plot of MET MET: Metformin
Figure 6
Figure 6
Chromatogram showing degraded peaks under acidic conditions
Figure 7
Figure 7
Chromatogram showing degraded peaks under alkali conditions
Figure 8
Figure 8
Chromatogram showing degraded peaks under oxidative conditions
Figure 9
Figure 9
Chromatogram showing degraded peaks under thermal conditions
Figure 10
Figure 10
Chromatogram showing degraded peaks under photostability conditions
Figure 11
Figure 11
Chromatogram showing degraded peaks under neutral conditions
See this image and copyright information in PMC

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