Department of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura 35516, Egypt.
J Food Drug Anal. 2016 Apr;24(2):441-449. doi: 10.1016/j.jfda.2015.11.006. Epub 2016 Jan 5.
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.
本研究建立并验证了一种简单、准确的高效液相色谱法，用于快速分离三种抗青光眼药物：马来酸噻吗洛尔（TM）、酒石酸溴莫尼定（BM）和拉坦前列素（LP）。使用 BDS Hypersil 苯基柱和流动相（乙腈：25mM 磷酸盐缓冲液，pH 4.0（50:50，v/v），流速为 1.2mL/min，在 210nm 处进行紫外检测，可在 6 分钟内完成三种药物的分离。该方法在 TM、BM 和 LP 的浓度范围为 5.0-200.0μg/mL、2.0-80.0μg/mL 和 1.0-25.0μg/mL 时呈线性，检测限分别为 0.21μg/mL、0.10μg/mL 和 0.11μg/mL。该方法用于测定两种治疗青光眼的固定剂量组合滴眼剂，其中含有 TM 与 BM 或 LP 中的一种。对含有研究药物的单成分眼科溶液的商业样品也进行了成功分析。通过学生 t 检验和方差比 F 检验对所提出方法的结果与比较方法的结果进行了比较。
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