Rossi Carlo, Fardella Giuseppe, Chiappini Ione, Perioli Luana, Vescovi Claudia, Ricci Maurizio, Giovagnoli Stefano, Scuota Stefania
Department of Chimica e Tecnologia del Farmaco, Via del Liceo 1, Università degli Studi di Perugia, 06123 Perugia, Italy.
J Pharm Biomed Anal. 2004 Oct 29;36(2):249-55. doi: 10.1016/j.jpba.2004.06.015.
Capreomycin (CS) is an antitubercular drug active against several Mycobacterium strains, in particular, against M. Avium. In spite of its activity, it is considered a second line drug because it can induce severe renal and hepatic damages when administered as free drug. However, it is possible to employ drug delivery systems, such as liposomes, to reduce the toxicity of the peptide without loss of its biological activity. For this purpose, appropriately validated time and money saving analytical methods are needed for a careful capreomycin dosage. In the present paper, UV spectroscopy and a reverse-phase HPLC (RP-HPLC) were investigated as alternative methods for capreomycin quantitative analysis. These techniques were validated against the USP XXVI microbiological turbidimetric assay and the normal-phase HPLC (NP-HPLC) method reported in the British Pharmacopoeia 2003. The results obtained showed that either UV spectrophotometry or RP-HPLC are techniques having higher accuracy and reproducibility with respect to the microbiological assay. Moreover, the RP-HPLC method provided improved performances if compared to NP-HPLC. In fact, RP-HPLC showed: (i) enhanced sensitivity and (ii) increased resolution. Thus we propose RP-HPLC and UV as valid alternative methods to the conventional procedures for capreomycin quantitative analysis.
卷曲霉素（CS）是一种抗结核药物，对多种分枝杆菌菌株有效，尤其是对鸟分枝杆菌。尽管它具有活性，但由于以游离药物形式给药时会引起严重的肾和肝损伤，因此被视为二线药物。然而，可以采用药物递送系统，如脂质体，来降低该肽的毒性而不损失其生物活性。为此，需要适当验证的省时省钱的分析方法来精确测定卷曲霉素的剂量。在本文中，研究了紫外光谱法和反相高效液相色谱法（RP-HPLC）作为卷曲霉素定量分析的替代方法。这些技术针对美国药典XXVI微生物比浊法和英国药典2003年报道的正相高效液相色谱法（NP-HPLC）进行了验证。所得结果表明，紫外分光光度法或RP-HPLC相对于微生物测定法具有更高的准确性和重现性。此外，与NP-HPLC相比，RP-HPLC方法具有更好的性能。事实上，RP-HPLC表现出：（i）灵敏度提高；（ii）分辨率增加。因此，我们建议将RP-HPLC和紫外法作为卷曲霉素定量分析常规方法的有效替代方法。
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