离子色谱法对甲硝唑片中亚硝酸盐含量的测定

发布时间：2018-02-10 07:41

本文关键词： 甲硝唑片离子色谱法亚硝酸盐　出处：《基因组学与应用生物学》2017年07期 　论文类型：期刊论文

【摘要】：为检测甲硝唑片中的亚硝酸盐含量,寻求科学合理的质量控制方法,本研究拟采用离子色谱法定量分析国药准字H20143031(青海绿色药业有限公司)、国药准字H64020164(宁夏金太阳药业有限公司)、国药准字H37021096(山东仁和制药有限公司)等三个企业生产的甲硝唑片中亚硝酸盐的含量,以亚硝酸根标准品为对照,制备甲硝唑片样品溶液,进样体积为100μL,分别计算分离度和理论塔板数检测系统可用性,绘制回归曲线得回归方程,检验该方法的精密度、重复性及稳定性,测定定量限,检测回收率和样品含量。结果显示,该方法检测亚硝酸根分离度2.5,理论塔板数3 000,该色谱峰系统可用;所得回归方程为y=11.696x-0.015 8,r=0.999 9,线性关系较好,精密度测定RSD为0.7%,重复性RSD为0.8%,稳定性RSD为0.7%,定量限为0.004 1μg/m L,平均回收率为99.0%,RSD为0.32%,说明该方法准确可靠;3个企业生产的甲硝唑片中亚硝酸盐含量分别为青海绿色药业有限公司(2.016μg/片)、宁夏金太阳药业有限公司(1.989μg/片)、山东仁和制药有限公司(2.015μg/片)。说明采用离子色谱法检测甲硝唑片中的亚硝酸盐含量,简便、准确且快速,值得推广应用。
[Abstract]:In order to detect nitrite content in metronidazole tablets, a scientific and reasonable quality control method was sought. The aim of this study is to use ion chromatography to quantitatively analyze the three enterprise students: H20143031 (Qinghai Green Pharmaceutical Co., Ltd.), H64020164 (Ningxia Jinyang Pharmaceutical Co., Ltd.) and H37021096 (Shandong Renhe Pharmaceutical Co., Ltd). Nitrite content in metronidazole tablets, Metronidazole sample solution was prepared by using nitrite standard as control. The sample volume was 100 渭 L. The system availability of separation degree and theoretical tray number were calculated, the regression equation was obtained by drawing the regression curve, and the precision of the method was tested. Repeatability and stability, quantitative limit, recovery rate and sample content were determined. The results showed that the separation degree of nitrite was 2.5, the number of theoretical trays was 3,000, and the chromatographic peak system was available. The precision, repeatability, stability, quantification limit and average recovery of metronidazole tablets were 0. 7, 0. 7, 0. 8, 0. 8, 0. 7, 0. 7, 0. 7, 0. 001 渭 g / mL and 0. 32, respectively, indicating that the method was accurate and reliable, and the nitrite content of metronidazole tablets produced by three enterprises was green in Qinghai province. Pharmaceutical Co., Ltd. 2. 016 渭 g / tablet, Ningxia Jinyang Pharmaceutical Co., Ltd. 1.989 渭 g / tablet, Shandong Renhe Pharmaceutical Co., Ltd. 2. 015 渭 g / tablet. Ion chromatography was used to determine nitrite content in metronidazole tablets. It is simple, accurate and fast. It is worth popularizing and applying.
【作者单位】：乐山职业技术学院;
【基金】：乐山职业技术学院资助
【分类号】：O657.7;R927.2

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