高级检索
当前位置: 首页 > 详情页

Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

单位: [1]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Pharm, Wuhan 430030, Peoples R China [2]Hainan Ctr Drugs & Med Devices Evaluat & Serv, Haikou, Peoples R China [3]ICAS Testing Technol Serv Shanghai Co Ltd, Shanghai, Peoples R China
出处:
ISSN:

关键词: Metronidazole benzoate elemental impurities inductively coupled plasma mass spectrometry International Council for Harmonization Q3D guidelines USP chapter <233>

摘要:
The elemental impurities in pharmaceutical products have aroused widespread concern among respective supervising authorities and official pharmacopoeias since they are harmful and have no therapeutic effects. Metronidazole benzoate is used extensively to treat a variety of infections. However, impurities will inevitably be introduced in the manufacturing process of metronidazole benzoate. Hence, in this study, a sensitive method was developed for trace determination of elemental impurities in metronidazole benzoate active pharmaceutical ingredients by using inductively coupled plasma mass spectrometry in kinetic energy discrimination mode. The method was validated for system suitability, specificity, linearity, sensitivity, accuracy, and precision according to USP chapter <233> Elemental Impurities-Procedure. The method had good linearity with correlation coefficients > 0.99. The limits of detection were in the range of 0.0003-0.1411 mu g/g, which was lower than the acceptable limit and indicated the high sensitivity of the method. The method was accurate with the recoveries in the range of 92%-107%. Moreover, the content of seven elemental impurities in the three batches of metronidazole benzoate active pharmaceutical ingredients by this method was originally below their limits and less than 30% of permitted daily exposure, meeting the requirement of International Council for Harmonization Q3D guidelines. Thus, this newly developed and validated method for estimating elemental impurities in metronidazole benzoate active pharmaceutical ingredients was within the permitted limit and suitable for routine use.

语种:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2023]版:
大类 | 4 区 化学
小类 | 4 区 物理:原子、分子和化学物理 4 区 光谱学
最新[2025]版:
大类 | 4 区 化学
小类 | 4 区 物理:原子、分子和化学物理 4 区 光谱学
JCR分区:
出版当年[2022]版:
Q3 SPECTROSCOPY Q4 PHYSICS, ATOMIC, MOLECULAR & CHEMICAL
最新[2023]版:
Q3 SPECTROSCOPY Q4 PHYSICS, ATOMIC, MOLECULAR & CHEMICAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者:
第一作者单位: [1]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Pharm, Wuhan 430030, Peoples R China
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:590 今日访问量:0 总访问量:442 更新日期:2025-06-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)