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N,N′-Ethylenebisstearamide Additive in Intravaginal Drug Delivery Device Determined by NP-LC with ELSD

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Abstract

A new method for N,N′-ethylenebisstearamide analysis was developed and validated in NP-LC with evaporative light scattering detection for EBS content in drug delivery device. Chromatographic conditions were silica column 250 × 3 mm at 45 °C with 94:6 CHCl3/ethanol at 0.5 mL min−1. The retention time of N,N′-ethylenebisstearamide was 4.35 min. The method was fully validated by applying a novel strategy using accuracy profiles. The EBS content in the progesterone device was established after administration in animal which proved that such additives did not migrate into the animal.

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Authors and Affiliations

  1. Laboratoire de Chimie Analytique, PPF Parasitologie-Pharmacie, UFR Pharmacie, Université Bordeaux 2, 146 rue Léo Saignat, 33076, Bordeaux cedex, France

    Tina Kauss, Karen Gaudin, Amina Mechraoui, Messaoud Bouhenika & Jean-Pierre Dubost

  2. Laboratoire CEVA Santé animale S. A., La ballastière, BP 126, 33501, Libourne cedex, France

    Laurence Peyrot

Authors
  1. Tina Kauss
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  2. Karen Gaudin
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  3. Amina Mechraoui
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  4. Messaoud Bouhenika
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  5. Laurence Peyrot
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  6. Jean-Pierre Dubost
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Correspondence to Tina Kauss.

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Kauss, T., Gaudin, K., Mechraoui, A. et al. N,N′-Ethylenebisstearamide Additive in Intravaginal Drug Delivery Device Determined by NP-LC with ELSD. Chroma 70, 1065–1071 (2009). https://doi.org/10.1365/s10337-009-1275-9

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  • DOI: https://doi.org/10.1365/s10337-009-1275-9

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