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Development and Validation of a Stability-Indicating Related Substances RP-HPLC Method for Anagliptin and its Degradation Products

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Pharmaceutical Chemistry Journal Aims and scope

There is no stability-indicating specific related substances high-performance liquid chromatography (HPLC) method for anagliptin active pharmaceutical ingredients in the presence of its degradation products. Hence, there is a necessity to have a specific stability-indicating HPLC method for the quantification of anagliptin-related substances in the presence of its forced degradation products. The aim of the research work is to develop an innovative simple, accurate, precise, and selective HPLC method with the lesser use of organic solvents, for the quantification of anagliptin-related substances in the presence of its forced degradation products. The chromatographic separation was achieved on a YMC Pro C18 reversed-phase HPLC column (250 mm × 4.6 mm, 5 μ) with a runtime of 50 min. Mobile phase A and mobile phase B were chlorate buffer with pH 3.2 and acetonitrile respectively. The HPLC column oven temperature was set at 28°C and the photodiode array detector was set at 205 nm. The proposed test procedure has shown excellent linearity within the concentration range 0.081–6.296 μg/mL with correlation coefficient (r) about 0.9998. The limit of detection of anagliptin and related substances was observed within the range 0.052–0.106) μg/mL and the limit of quantification was observed within the range 0.156–0.317 μg/mL. The developed test procedure was successfully utilized for the quantification of related substances of anagliptin bulk drug without any interference with the degradation compounds. Hence, the test procedure can be utilized successfully in pharmaceutical organizations for the separation and quantification of anagliptin-related substances.

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Acknowledgements

The authors are thankful to Lupin Pharmaceutical Ltd (Tarapur, India) for providing gratis samples for the present studies.

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Authors and Affiliations

  1. Department of Chemistry, Maulana Azad College, Aurangabad, 431001, (M.S.), India

    Rajendra S. Chavan, Abdul Ahad, Sabreena Yameen & Pathan Mohd Arif

  2. Wockhardt Research Centre, Aurangabad, 431006, (M.S.), India

    Rajendra S. Chavan

  3. LBS Senior College Partur, Jalna, (M.S.), India

    Rajendra Phase

  4. Maulana Azad National Urdu University, Hyderabad, (M.S.), India

    Qasim Ullah

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  1. Rajendra S. Chavan
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  2. Abdul Ahad
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Correspondence to Pathan Mohd Arif.

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Chavan, R.S., Ahad, A., Phase, R. et al. Development and Validation of a Stability-Indicating Related Substances RP-HPLC Method for Anagliptin and its Degradation Products. Pharm Chem J 57, 1314–1322 (2023). https://doi.org/10.1007/s11094-024-03040-1

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  • DOI: https://doi.org/10.1007/s11094-024-03040-1

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