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首页> 外文期刊>The Journal of Antibiotics: An International Journal >Simultaneous determination of purity and potency of amphotericin B by HPLC.
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Simultaneous determination of purity and potency of amphotericin B by HPLC.

机译：通过HPLC同时测定两性霉素B的纯度和效力。

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Currently, the quality-control strategy of amphotericin B in US Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia and Pharmacopoeia of the People's Republic of China all adopt the combination of purity measurement by HPLC and potency measurement by microbiological assay. In this study, we prepared pure amphotericin B and quantified the relationship between amphotericin B content and potency values using the mass-balance method and microbiological assay. The potency of amphotericin B with an absolute purity of 100% was determined to be 1048.63 U mg(-1). An HPLC method was then established to simultaneously determine the content and potency of amphotericin B, which unified the quality-control procedure for amphotericin B. A good linear relationship was observed between the peak area and the concentration, which could be expressed as y=113074x+4196.5, R(2)=0.9999. The lower limit of quantification was 0.4473 ng. The HPLC method is expected to become the routine quality-control method and replace the current laborious quality-control procedure in pharmacopoeias.
机译：目前，《美国药典》，《英国药典》，《欧洲药典》和《中华人民共和国药典》中的两性霉素B的质量控制策略，均采用HPLC纯度测定与微生物测定效价测定相结合的方法。在这项研究中，我们制备了纯两性霉素B，并使用质量平衡法和微生物测定法定量了两性霉素B含量与效价值之间的关系。确定绝对纯度为100％的两性霉素B的效力为1048.63 U mg（-1）。建立了同时测定两性霉素B含量和效价的HPLC方法，统一了两性霉素B的质量控制程序。在峰面积与浓度之间观察到良好的线性关系，可以表示为y = 113074x + 4196.5，R（2）= 0.9999。定量下限为0.4473 ng。 HPLC方法有望成为常规的质量控制方法，并取代目前药典中费力的质量控制程序。

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