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Quantitative characterization and pharmaceutical compatibility between teneligliptin and widely used excipients by using thermal and liquid chromatography tandem mass spectrometry techniques

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Abstract

The aim of this work was to evaluate the quantitative characterization and pharmaceutical compatibility study of teneligliptin (TNG) with the commonly used excipients for solid dosage form employing thermogravimetric analysis, differential scanning calorimetry, liquid chromatography–mass spectrometer, powder X-ray diffraction, isothermal stress testing, optical microscopy and Fourier transform infrared spectroscopy as a supporting technique to contribute to the interpretation of results. The selected excipients were magnesium stearate (MS), sodium starch glycolate (SSG), croscarmellose sodium (CCS), pregelatinized starch (PS) and microcrystalline cellulose (MCC). On the basis of the DSC results, some interactions were found with TNG–CCS, TNG–MCC, TNG–MS, TNG–SSG and TNG–PS. However, during IST studies less than 3% change in TNG content was observed in all stressed binary mixtures except TNG–CCS, TNG–SSG (< 10%) which showed incompatibility with TNG. These results would be suitable for the formulation development of the solid dosage forms of TNG.

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Acknowledgements

The author Faraat Ali is grateful to Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Govt. of India, India, for providing necessary instrumental facilities. All the authors have no conflict of interest regarding this publication. This article does not contain any studies with human and animal subjects applied by any of the authors.

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Authors and Affiliations

  1. Pharmaceutical Chemistry Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare Government of India, Sector-23, Rajnagar, Ghaziabad, Uttar Pradesh, 201002, India

    Faraat Ali, Manisha Trivedi, Anuj Prakash, Meenakshi Dahiya, Puran Lal Sahu, Robin Kumar & Gyanendra Nath Singh

  2. PK-PD and Toxicology Division, Indian Institute of Integrative Medicine (CSIR), Canal Road, Jammu Tawi, Jammu, Jammu and Kashmir, 180001, India

    Utpal Nandi

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  1. Faraat Ali
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Ali, F., Nandi, U., Trivedi, M. et al. Quantitative characterization and pharmaceutical compatibility between teneligliptin and widely used excipients by using thermal and liquid chromatography tandem mass spectrometry techniques. J Therm Anal Calorim 132, 385–396 (2018). https://doi.org/10.1007/s10973-018-6962-z

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  • DOI: https://doi.org/10.1007/s10973-018-6962-z

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