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首页> 外文期刊>Journal of Microbiology, Biotechnology and Food Sciences >VALIDATED MICROBIOLOGICAL ASSAY FOR JOSAMYCIN DETERMINATION IN ITS PHARMACEUTICAL FORMULATIONS
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VALIDATED MICROBIOLOGICAL ASSAY FOR JOSAMYCIN DETERMINATION IN ITS PHARMACEUTICAL FORMULATIONS

机译：验证的josamycin测定的微生物测定在其药物制剂中的测定

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摘要

A simple, inexpensive and efficient agar diffusion bioassay, applying cylinder plate method, for determination of josamycin (JOS) in pure and pharmaceutical dosage forms was studied. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, JOS at concentrations ranging from 0.1 to 0.5 μg/mL could be measured. The calibration graph was linear with good correlation coefficient (r = 0.999), and the method validation showed that it was specific and robust. The interference effects of degradation products and excipients were investigated in order to assess the method selectivity. The proposed method was successfully applied to estimate JOS content in tablets and suspension with good precision (intra-day RSD=0.87%; inter-day RSD=1.25%) and accuracy; the recovery values were between 97.74 and 101.13%. Bioassay was correlated with UV spectrophotometric and high performance liquid chromatographic techniques. The results obtained by these three methods were statistically analyzed by analysis of variance (ANOVA), which indicated that there was no significant difference among these methods. Therefore, we recommend this microbiological assay for drug analysis in routine quality control of josamycin in pharmaceuticals as an alternative to the physicochemical methods reported in the literature.
机译：研究了一种简单，廉价且高效的琼脂扩散生物测定，施加汽缸板方法，用于纯和药物剂型中的josamycin（JOS）的测定。使用菌株的微球菌ATCC 9341作为测试生物，可以测量浓度为0.1至0.5μg/ ml的JOS。校准图是线性的，相关系数良好（R = 0.999），方法验证表明它是特异性和鲁棒的。研究了降解产物和赋形剂的干扰效应，以评估方法选择性。该方法已成功应用于估计片剂中的JOS含量和悬浮液，具有良好的精度（日期RSD = 0.87％;日内RSD = 1.25％）和准确性;回收值介于97.74和101.13％之间。生物测定与紫外分光光度法和高性能液相色谱技术相关。通过对方差（ANOVA）的分析，通过以下三种方法获得的结果，表明这些方法中没有显着差异。因此，我们建议这种微生物测定用于药物中Josamycin常规控制的药物分析，作为文献中报告的物理化学方法的替代品。

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