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A Rapid and Sensitive LC Method for Determination of Diastereomeric Purity of Tenofovir Alafenamide

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Abstract

A rapid and sensitive LC method was developed and validated for the determination of diastereomeric purity of tenofovir alafenamide (GS-7340). Baseline separation with resolution >2.8 was achieved within 17 min on a CHIRALPAK AD-3 (250 × 4.6 mm; particle size 3 μm) column using n-hexane:2-propanol (60:40 v/v) as the mobile phase at a flow rate of 1 mL min−1. The analytes were detected by UV absorbance at 260 nm. The effects of ethanol, 2-propanol, and temperature on diastereomeric selectivity and resolution of diastereomerism were evaluated. The method was extensively validated and proved to be robust. The recoveries were between 98.17 and 102.84 % with <1.93 % relative standard deviation. The limit of detection and limit of quantitation for GS-7339 were 0.77 and 2.56 μg mL−1 and for GS-7340 were 0.61 and 2.04 μg mL−1, respectively. This method was extensively proved to be accurate, stable, rapid, and sensitive for the determination of diastereomeric purity of tenofovir alafenamide (GS-7340) in bulk samples.

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Authors and Affiliations

  1. State Key Laboratory of Biotherapy/Collaborative Innovation Center of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu, 610041, China

    Mingxing Hu, Qi Wang, Chao Yang, Hongbao Sun, Jie Liu, Yiwen Zhang & Yongmei Xie

  2. Department of Pharmacology, West China School of Preclinical and Forensic Medicine, Sichuan University, Chengdu, 610041, China

    Xiuying Ma

Authors
  1. Mingxing Hu
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  2. Qi Wang
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  3. Xiuying Ma
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  4. Chao Yang
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  5. Hongbao Sun
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  6. Jie Liu
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  7. Yiwen Zhang
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  8. Yongmei Xie
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Corresponding authors

Correspondence to Yiwen Zhang or Yongmei Xie.

Additional information

M. Hu and Q. Wang contributed equally to this work.

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Hu, M., Wang, Q., Ma, X. et al. A Rapid and Sensitive LC Method for Determination of Diastereomeric Purity of Tenofovir Alafenamide. Chromatographia 77, 1399–1403 (2014). https://doi.org/10.1007/s10337-014-2745-2

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  • DOI: https://doi.org/10.1007/s10337-014-2745-2

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