液相色谱法测定药物制剂中的制霉菌素
Liquid chromatographic determination of nystatin in pharmaceutical preparations.
作者信息
Wilson P, Stewart A, Flournoy V, Zito S W, Vancura A
机构信息
US Food and Drug Administration, NRL, Jamaica, NY 11433, USA.
出版信息
J AOAC Int. 2001 Jul-Aug;84(4):1050-5.
A rapid, reversed-phase liquid chromatographic method was developed for the assay of nystatin in the bulk drug and a variety of dosage forms. Analysis was performed on a Symmetry C18 reversed-phase column using a mobile phase of methanol-water-dimethylformamide (DMF; 55 + 30 + 15, v/v/v), with detection by UV at 305 nm. Quantitation is based on the sum of the peak areas of the 2 major isomers of nystatin. The linearity of the assay was determined for a concentration range of 0.05 to 0.2 mg/mL (correlation coefficient > 0.999). Accuracies and precision showed good reproducibility.
建立了一种快速反相液相色谱法，用于原料药及多种剂型中制霉菌素的含量测定。分析在Symmetry C18反相柱上进行，流动相为甲醇-水-二甲基甲酰胺（DMF；55 + 30 + 15，v/v/v），于305 nm处采用紫外检测。定量基于制霉菌素2种主要异构体的峰面积之和。该测定法在0.05至0.2 mg/mL的浓度范围内测定线性（相关系数>0.999）。准确度和精密度显示出良好的重现性。
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