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A stability-indicating HPLC method for the determination of 17β-estradiol-3-phosphate in an ophthalmic solution

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Summary

A reversed-phase high-performance liquid chromatographic (HPLC) procedure using ultra-violet (UV) detection for the analysis of 17β-estradiol-3-phosphate in an ophthalmic solution is reported. The method is selective, accurate, and reproducible. The peak area versus 17β-estradiol-3-phosphate concentration is linear over the range of 50–150% of its label claim of 1.0 mg/mL, with a detection limit of 20 ng/mL. The mean absolute recovery of 17β-estradiol-3-phosphate using the described method is 99.8±0.6% (mean ±SD, n=10). A stress study with heat, acid, base and UV radiation indicates that the method is stability-indicating with no interference from excipients or degradation products.

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  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

    R. B. Miller & C. Chen

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  1. R. B. Miller
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  2. C. Chen
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Miller, R.B., Chen, C. A stability-indicating HPLC method for the determination of 17β-estradiol-3-phosphate in an ophthalmic solution. Chromatographia 40, 204–206 (1995). https://doi.org/10.1007/BF02272172

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  • DOI: https://doi.org/10.1007/BF02272172

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