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首页> 美国卫生研究院文献>Journal of Pharmaceutical Analysis >Rapid simple and stability-indicating determination of polyhexamethylene biguanide in liquid and gel-like dosage forms by liquid chromatography with diode-array detection
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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

机译：液相色谱-二极管阵列检测法快速简单稳定地测定液体和凝胶状剂型中的聚六亚甲基双胍

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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×75 mm with particle size of 3.5 μm) as well as gradient elution consisting of acetonitrile/deionized water at a flow rate of 1.0 mL/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 chromatographic procedure 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.
机译：建立了一种快速，简单的高效液相色谱-二极管阵列检测（HPLC-DAD）方法测定液体和凝胶状药物制剂中的聚六亚甲基双胍（聚己二酰，PHMB）的方法。最好的分离方法是使用氰丙基键合相（Agilent Zorbax Eclipse XDB-CN色谱柱4.6mm×75mm，粒径3.5μm）以及由乙腈/去离子水组成的梯度洗脱液，流速为1.0mL / min。优化的色谱条件和应用的色谱条件允许从相互作用的基质中分离出聚己酮，并随后在235 nm波长处以良好的灵敏度进行检测。方法验证是根据国际协调会议（ICH）要求的分析程序指南进行的。凝胶状和液体制剂的平均回收率分别为102％和101％。两种制剂的检出限均≤0.004mg / mL，可实现合适的重复性和中间精度，相当于样品制备的≤0.004％PHMB。无需繁琐的样品制备即可完成PHMB的测定。色谱法可以消除相互作用的基质，具有出色的系统适用性。满足所有分析要求，可以可靠，精确地测定药物中的PHMB。此外，将开发的方法用于含PHMB的药物制剂的稳定性测试。

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