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Size exclusion chromatographic determination of hydroxypropyl methyl cellulose and polyethylene glycol 400 in an ophthalmic solution

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Summary

Hydroxypropyl methyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400) content in HypoTears™ Daily Dose ophthalmic solution are determined simultaneously by size exclusion chromatography. The retention times of HPMC and PEG 400 are 10.6 and 15.4 minutes, respectively. The method requires minimal sample pretreatment and is accurate and reproducible. The peak area response from a refractive index detector versus HPMC and PEG 400 concentration is linear over the range of 50–150 % of their label claims of 2.5 mg/mL and 10 mg/mL, respectively. The mean absolute recoveries of HPMC and PEG 400 at their label claim using the described method are 98.9±1.3 % and 100.4±1.2 % (mean±SD, n=12), respectively.

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Author notes

  1. R. B. Miller

    Present address: Pharmaceutical Sciences, Fujisawa USA, Inc., 2045 N. Cornell Ave., 60160, Melrose Park, IL, USA

Authors and Affiliations

  1. Pharmaceutical Development Department, IOLAB Corporation (a Johnson & Johnson Company), 500 Iolab Drive, 91711, Claremont, CA, USA

    G. Delker, C. Chen & R. B. Miller

  2. CIBA Vision Ophthalmics, 11460 Johns Creek Parkway, 30136, Duluth, GA, USA

    G. Delker, C. Chen & R. B. Miller

Authors
  1. G. Delker
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  2. C. Chen
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  3. R. B. Miller
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Delker, G., Chen, C. & Miller, R.B. Size exclusion chromatographic determination of hydroxypropyl methyl cellulose and polyethylene glycol 400 in an ophthalmic solution. Chromatographia 41, 263–266 (1995). https://doi.org/10.1007/BF02688038

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  • DOI: https://doi.org/10.1007/BF02688038

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