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Validation of a Stability-indicating RP-LC Method for the Assessment of Recombinant Human Interleukin-11 and Its Correlation with Bioassay

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Abstract

A stability-indicating reversed-phase liquid chromatography (RP-LC) method was validated for the assessment of recombinant human interleukin-11 (rhIL-11), based on the ICH guidelines. The method was carried out on a Jupiter C4 column (250 mm × 4.6 mm i.d.), maintained at 25°C. The mobile phase A consisted of 0.1% trifluoroacetic acid (TFA) and the mobile phase B was acetonitrile with 0.1% TFA, run at a flow rate of 1 mL/min, and using a photodiode array (PDA) detection at 214 nm. Separation was obtained with a retention time of 27.6 min, and was linear over the concentration range of 1 – 200 µg/mL (r2 = 0.9995). Specificity was established in degradation studies, which also showed that there was no interference of the excipients. The accuracy was 100.22% with bias lower than 1.25%. Moreover, the in vitro cytotoxicity test of the degraded products showed non-significant differences (p > 0.05). The method was applied to the assessment of rhIL-11 and related proteins in biopharmaceutical dosage forms, and the results were correlated to those of a bioassay.

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Authors and Affiliations

  1. Department of Industrial Pharmacy, Federal University of Santa Maria, 97105-900, Santa Maria, RS, Brazil

    Ricardo Bizogne Souto, Fernanda Pavani Stamm, Guilherme Zanini Calegari & Sérgio Luiz Dalmora

  2. Biotechnology Department, IPEN-CNEN, Cidade Universitária, 05508-900, São Paulo, SP, Brazil

    Maria Teresa Carvalho Pinto de Ribela & Paolo Bartolini

Authors
  1. Ricardo Bizogne Souto
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  2. Fernanda Pavani Stamm
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  3. Maria Teresa Carvalho Pinto de Ribela
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  4. Paolo Bartolini
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  5. Guilherme Zanini Calegari
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  6. Sérgio Luiz Dalmora
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Correspondence to Sérgio Luiz Dalmora.

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Souto, R.B., Stamm, F.P., de Ribela, M.T.C.P. et al. Validation of a Stability-indicating RP-LC Method for the Assessment of Recombinant Human Interleukin-11 and Its Correlation with Bioassay. ANAL. SCI. 28, 215–220 (2012). https://doi.org/10.2116/analsci.28.215

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  • DOI: https://doi.org/10.2116/analsci.28.215

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