Abstract
Fast and simple hydrophilic interaction liquid chromatography (HILIC) method was developed and validated for the analysis of moxonidine and its four impurities (A, B, C, and D) in pharmaceutical dosage form. All experiments were performed on the Agilent Technologies 1200 high-performance liquid chromatography (HPLC) system using Zorbax RX-SIL, 250 mm × 4.6 mm, 5 μm column as stationary phase (T = 25°C, F = 1 mL/min, and λ = 255 nm), and mixture of acetonitrile and 40 mM ammonium formate buffer (pH 2.8) 80 : 20 (v/v) as mobile phase. Under the optimal chromatographic conditions, selected by central composite design, separation and analysis of moxonidine and its four impurities are enabled within 12 minutes. Validation of the method was conducted in accordance with ICH guidelines. Based on the obtained results selectivity, linearity (r ≥ 0.9976), accuracy (recovery: 93.66%–114.08%), precision (RSD: 0.56%–2.55%), and robustness of the method were confirmed. The obtained values of the limit of detection and quantification revealed that the method can be used for determination of impurities levels below 0.1%. Validated method was applied for determination of moxonidine and its impurities in commercially available tablet formulation. Obtained results confirmed that validated method is fast, simple, and reliable for analysis of moxonidine and its impurities in tablets.
Highlights
Moxonidine belongs to the second generation of centrally acting antihypertensive drugs that exhibit high binding affinity for I1-imidazoline receptor and minor activity at α2adrenoceptors which explains the absence of adverse effects characteristic for the first generation of antihypertensives such as sedation and dry mouth
In order to avoid the application of ion-pair reagent which enables adequate retention of compounds or micellar liquid chromatography (MLC) which is suitable for simultaneous determination of ionic and nonionic compounds [5, 6], analysis of ionized molecules can be performed by hydrophilic interaction liquid chromatography (HILIC) method
This method is described as a useful alternative to reverse phase chromatography in which the polar columns, such as silica and amino, are used as the stationary phase and water/buffer solution with high volume ratio of an organic solvent as a mobile phase [7, 8]
Summary
Moxonidine belongs to the second generation of centrally acting antihypertensive drugs that exhibit high binding affinity for I1-imidazoline receptor and minor activity at α2adrenoceptors which explains the absence of adverse effects characteristic for the first generation of antihypertensives such as sedation and dry mouth. In order to avoid the application of ion-pair reagent which enables adequate retention of compounds or micellar liquid chromatography (MLC) which is suitable for simultaneous determination of ionic and nonionic compounds [5, 6], analysis of ionized molecules can be performed by hydrophilic interaction liquid chromatography (HILIC) method. This method is described as a useful alternative to reverse phase chromatography in which the polar columns, such as silica and amino, are used as the stationary phase and water/buffer solution with high volume ratio of an organic solvent as a mobile phase [7, 8]
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