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Ultra HPLC Method for Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone: Identification and in silico Toxicity Prediction of Degradation Products

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Abstract

The fixed dose combination of azilsartan medoxomil potassium and chlorthalidone has been introduced for the effective treatment of hypertension. In the present work a rapid, simple and accurate stability indicating ultra HPLC assay method has been developed. The separation of azilsartan medoxomil, chlorthalidone and their degradation products were accomplished on an Acquity UPLC BEH C18 (100 mm × 2.1 mm, 1.7 μm) column using mobile phase combination of 0.02% trifluoroacetic acid in water and acetonitrile in gradient mode. The forced degradation products were identified using liquid chromatography‒electrospray ionisation-quadrupole time of flight-tandem mass spectrometry (LC‒ESIQTOF–MS/MS) and accurate mass experiments. The in silico toxicities of the degradation products for both the drugs were evaluated. The proposed method was validated as per the ICH Q2 (R1) guideline for selectivity, linearity, precision, accuracy and robustness.

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Authors and Affiliations

  1. National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, Telangana, India

    Gananadhamu Samanthula & Debasish Swain

  2. United States Pharmacopeia (USP) India Pvt. Ltd., Hyderabad, Telangana, India

    Gayatri Sahu

  3. National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Mohali, Punjab, India

    Shweta Bhagat & P. V. Bharatam

Authors
  1. Gananadhamu Samanthula
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  2. Debasish Swain
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  3. Gayatri Sahu
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  4. Shweta Bhagat
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  5. P. V. Bharatam
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Correspondence to Gananadhamu Samanthula.

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Samanthula, G., Swain, D., Sahu, G. et al. Ultra HPLC Method for Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone: Identification and in silico Toxicity Prediction of Degradation Products. J Anal Chem 73, 560–569 (2018). https://doi.org/10.1134/S1061934818060138

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  • DOI: https://doi.org/10.1134/S1061934818060138

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