Salgado H R N, Lopes C C G O, Lucchesi M B B
Programa de Pós-graduação em Ciências Farmacêuticas, Faculdade de Ciências Farmacêuticas, Universidade Estadual Paulista, Rod. Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SP, Brazil.
J Pharm Biomed Anal. 2006 Feb 13;40(2):443-6. doi: 10.1016/j.jpba.2005.07.020. Epub 2005 Sep 1.
A simple, sensitive and specific agar diffusion bioassay for the antibacterial gatifloxacin was developed using a strain of Bacillus subtilis ATCC 9372 as the test organism. Gatifloxacin could be measured in tablets and raw material at concentration ranging 4-16 microgml(-1). The calibration graph for gatifloxacin was linear from 4.0 to 16.0 microgml(-1). A prospective validation of the method demonstrated that the method was linear (r2=0.9993), precise (R.S.D.=1.14%) and accurate. The results confirmed its precision and did not differ significantly from others methods described in the literature. The validated method yielded good results in terms of the range, linearity, precision, accuracy, specificity and recovery. We concluded that the microbiological assay is satisfactory for in vitro quantification of the antibacterial activity of gatifloxacin.
以枯草芽孢杆菌ATCC 9372菌株作为测试菌，开发了一种用于抗菌药物加替沙星的简单、灵敏且特异的琼脂扩散生物测定法。加替沙星可在片剂和原料药中进行测定，浓度范围为4 - 16微克/毫升。加替沙星的校准曲线在4.0至16.0微克/毫升范围内呈线性。该方法的前瞻性验证表明，该方法具有线性（r2 = 0.9993）、精密度高（相对标准偏差=1.14%）且准确度高。结果证实了其精密度，与文献中描述的其他方法相比无显著差异。该验证方法在范围、线性、精密度、准确度、特异性和回收率方面均取得了良好结果。我们得出结论，微生物测定法对于加替沙星抗菌活性的体外定量是令人满意的。
