Abstract
BackgroundA simple, rapid and accurate stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) was developed and validated for the determination of brimonidine tartrate in brimonidine tartrate/poly(2-hydroxyethyl methacrylate) (BRI/PHEMA) drug delivery contact lenses and pharmaceutical formulations.ResultsOptimum chromatographic conditions for separating brimonidine tartrate from other impurities in the leaching liquor of BRI/PHEMA drug delivery contact lenses or pharmaceutical formulations have been achieved by using a Diamonsil C18 column (150 mm × 4.6 mm, 5 μm) as a stationary phase and a mixture solution of phosphate buffer (10 mM, pH3.5) containing 0.5% triethlamine and methanol (85:15, v/v) as a mobile phase at a flow rate of 1 mL/min. The theoretical plates for the brimonidine tartrate measurement were calculated to be 8360 when detection was performed at 246 nm using a diode array detector. The proposed method was validated in accordance with ICH guidelines with respect to linearity, accuracy, precision, robustness, specificity, limit of detection and quantitation. Regression analysis showed a good correlation (R2 > 0.999) for brimonidine tartrate in the concentration range of 0.01–50 μg/mL. The peak purity factor is ≥980 for the analyte after all types of stress tests, indicating an excellent separation of brimonidine tartrate peak from other impurities. The measurement course could be completed within 10 min, which was very quick, effective and convenient.ConclusionsOverall, the proposed stability-indicating method was suitable for routine quality control and drug analysis of brimonidine tartrate in BRI/PHEMA drug delivery contact lenses and other pharmaceutical formulations.
Highlights
Glaucoma is an ocular disease characterized by elevated intraocular pressure (IOP) and progressive optic neuropathy, leading to visual loss [1]
Preparation of brimonidine tartrate (BRI)/Poly(2-hydroxyethyl methacrylate) (PHEMA) contact lens In the preparation course of a BRI/PHEMA contact lens, the monomer hydroxyethyl methacrylate (HEMA) and the PEG-DMA were copolymerized by initiating with a UV light free radical initiator D2959
A PHEMA film can be obtained at room temperature
Summary
Glaucoma is an ocular disease characterized by elevated intraocular pressure (IOP) and progressive optic neuropathy, leading to visual loss [1]. Decreasing and maintaining IOP by means of topical drug administration is the most direct and preferred treatment options to treat glaucoma. Brimonidine [5-bromo-6-(2-imidazolidinylideneamino) quinoxaline] is a highly selective α2-adrenoceptor agonist which can lower IOP and is approved for topical ocular administration for glaucoma treatments. Brimonidine tartrate (shown in Fig. 1) can lower IOP [2], and protective optic nerve and limit the progression of visual loss in glaucoma [3]. The topical administration of brimonidine tartrate eye drops has low bioavailability through the cornea (1–7%), and the remaining drug which enters systemic circulation can cause side effects [4]. A simple, rapid and accurate stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) was developed and validated for the determination of brimonidine tartrate in brimonidine tartrate/ poly(2-hydroxyethyl methacrylate) (BRI/PHEMA) drug delivery contact lenses and pharmaceutical formulations
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