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Abstract

In this study, a simple and accurate high-performance liquid chromatography method was developed and validated for fast separation of three anti-glaucoma drugs: timolol maleate (TM), brimonidine tartrate (BM), and latanoprost (LP). Separation of the three drugs was achieved in < 6 minutes using a BDS Hypersil phenyl column and a mobile phase consisting of acetonitrile: 25mM phosphate buffer, pH 4.0 (50: 50, v/v) at 1.2 mL/min with UV detection at 210 nm. The method was linear over the concentration ranges of 5.0-200.0 μg/mL, 2.0-80.0 μg/mL and 1.0-25.0 μg/mL with lower detection limits of 0.21 μg/mL, 0.10 μg/mL and 0.11 μg/mL for TM, BM and LP, respectively. The method was applied for the determination of two fixed-dose combination eye drops for the treatment of glaucoma, containing TM together with either BM or LP. Commercial samples of single-ingredient ophthalmic solutions containing the studied drugs were also successfully analyzed. The results obtained by the proposed method were favorably compared with those obtained by the comparison methods using Student's t test and the variance ratio F test. Copyright © 2016, Food and Drug Administration, Taiwan. Published by Elsevier Taiwan LLC.

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ScienceDirect Link

10.1016/j.jfda.2015.11.006

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

Fulltext URL

https://www.sciencedirect.com/science/article/pii/S1021949815001489/pdfft?md5=2382e03db467da0b8d457508bc4675f3&pid=1-s2.0-S1021949815001489-main.pdf

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