• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Chromatographia >A validated LC method for determination of the enantiomeric purity of montelukast sodium in bulk drug samples and pharmaceutical dosage forms
【24h】

A validated LC method for determination of the enantiomeric purity of montelukast sodium in bulk drug samples and pharmaceutical dosage forms

机译：经验证的液相色谱法测定散装药物样品和药物剂型中孟鲁司特钠的对映体纯度

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

A new and accurate chiral liquid chromatographic method has been developed for determination of the enantiomeric purity of montelukast sodium (R enantiomer) in bulk drugs and dosage forms. Normal phase chromatographic separation was performed on an immobilized amylose-based chiral stationary phase with n-hexane-ethanol-1,4-dioxane-trifluoroacetic acid-diethylamine 65:25:10:0.3:0.05 (v/v) as mobile phase at a flow rate of 1.0 mL min(-1). The elution time was approximately 15 min. The resolution (R-S) between the enantiomers was > 3. The mobile phase additives trifluoroacetic acid and diethylamine played a key role in achieving chromatographic resolution between the enantiomers and also in enhancing chromatographic efficiency. Limits of detection and quantification for the S enantiomer were 0.07 and 0.2 mu g, respectively, for a test concentration of montelukast sodium of 1,000 mu g mL(-1) and 10 mu L injection volume. The linearity of the method for the S enantiomer was excellent (R-2 > 0.999) over the range from the LOQ to 0.3%. Recovery of the S enantiomer from bulk drug samples and dosage forms ranged from 97.0 to 103.0%, indicative of the high accuracy of the method. Robustness studies were also conducted. The sample solution stability of montelukast sodium was determined and the compound was found to be stable for a study period of 48 h.
机译：已开发出一种新的准确的手性液相色谱方法，用于测定散装药物和剂型中孟鲁司特钠（R对映异构体）的对映体纯度。正相色谱分离是在固定的直链淀粉基手性固定相上进行的，其中正己烷-乙醇-1,4-二恶烷-三氟乙酸-二乙胺65：25：10：0.3：0.05（v / v）为流动相流速为1.0 mL min（-1）。洗脱时间约为15分钟。对映体之间的分离度（R-S）>3。流动相添加剂三氟乙酸和二乙胺在实现对映体之间的分离度和提高色谱效率方面起着关键作用。 S对映异构体的检出限和定量限分别为1,000μg mL（-1）和10μL注射量的孟鲁司特钠测试浓度，分别为0.07和0.2μg。在LOQ至0.3％的范围内，S对映异构体的方法线性很好（R-2> 0.999）。从散装药物样品和剂型中回收的S对映体的比例为97.0％至103.0％，这表明该方法具有很高的准确性。还进行了稳健性研究。测定孟鲁司特钠的样品溶液稳定性，发现该化合物在48小时的研究期内稳定。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号