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Rapid,simple and stability-indicating determination of polyhexamethylene biguanide in liquid and gel-like dosage forms by liquid chromatography with diode-array detection

查看全文 作　　者：Markus [1]Küsters;Soren [1]Beyer;Stephan [1]Kutscher;Harald [1]Schlesinger;Michael [2]Gerhartz 高影响力作者 机构地区：[1]Central Hospital of the German Federal Armed Forces Koblenz,Pharmacy Section;[2]Central Institute of the German Federal Armed Forces Koblenz,Laboratory Department of Food and Environmental Chemistry高影响力机构 出　　处：《Journal of Pharmaceutical Analysis》索引2013年第3卷第6期,共7页高影响力期刊 摘　　要：A rapid and simple method for the determination of polyhexamethylene biguanide(polyhexanide,PHMB)in liquid and gel-like pharmaceutical formulations by means of high performance liquid chromatography coupled to diode-array detection(HPLC-DAD)was developed.Best separation was achieved using a cyanopropyl bonded phase(Agilent Zorbax Eclipse XDB-CN column 4.6 mm x 75 mm with particle size of 3.5μm)as well as gradient elution consisting of acetonitrile/deionized water at a flow rate of 1.0mL/min.The optimized and applied chromatographic conditions permitted separation of polyhexanide from interacting matrix with subsequent detection at a wavelength of 235 nm with good sensitivity.The method validation was carried out with regard to the guidelines for analytical procedures demanded by the International Conference on Harmonisation(ICH).Mean recoveries of 102%and 101%for gel-like as well as liquid preparations were obtained.Suitable repeatability as well as intermediate precision could be achieved with limits of detection≤0.004 mg/mL for both formulations,equivalent to≤0.004%PHMB concerning sample preparation.Determination of PHMB was accomplished without tedious sample preparation.Interacting matrix could be eliminated by the chromatographicprocedure with excellent performance of system suitability.All analytical requirements were fulfilled permitting a reliable and precise determination of PHMB in pharmaceuticals.Furthermore,the developed method was applied to stability testing of pharmaceutical preparations containing PHMB. 关 键 词：Polyhexamethylene BIGUANIDE Polyhexanide Pharmaceuticals High performance liquid CHROMATOGRAPHY
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