British pharmacopoeia 2011 pdf
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In recent years, new formulations such as liposomal amphotericin B have been developed that have significantly reduced toxicity and side effects, and amphotericin B has regained wide clinical application. However, its adverse effects, such as serious renal toxicity, have restricted its clinical application. 1, 2, 3 Amphotericin B is the preferred drug for deep fungal infection. Amphotericin B changes the permeability of cell membrane by combining with ergosterol on the fungal cell membrane to result in intracellular sodium and potassium ion leakage, thus killing the fungal cells. Its molecular formula is C 47H 73NO 17, and its chemical structure is shown in Figure 1. The HPLC method is expected to become the routine quality-control method and replace the current laborious quality-control procedure in pharmacopoeias.Īmphotericin B is a polyene antifungal antibiotic produced by Streptomyces nodosus. The lower limit of quantification was 0.4473 ng. A good linear relationship was observed between the peak area and the concentration, which could be expressed as y=113074 x+4196.5, R 2=0.9999. 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.
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The potency of amphotericin B with an absolute purity of 100% was determined to be 1048.63 U mg –1. 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. 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.