• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of the Chilean Chemical Society >STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY
【24h】

STABILITY STUDY AND VALIDATED REVERSED PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF TIROFIBAN HYDROCHLORIDE IN PRESENCE OF TYROSINE AS A PROCESS IMPURITY

机译：酪氨酸作为工艺杂质存在时的稳定性研究和验证的反相液相色谱法测定盐酸替罗非班

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Tirofiban hydrochloride was subjected to the degradation under conditions of hydrolysis (acidic and alkaline degradation), oxidative, thermal and photolytic degradation as prescribed by ICH. A simple and precise liquid chromatographic method has been developed and validated for the simultaneous determination of tirofiban hydrochloride monohydrate (TIR) and its synthetic starting material; tyrosine (TRS). All the chromatographic separations were achieved on Zorbax SB C18, 250 mm??4.6 mm i.d., 5μm column at a flow rate of 1 mL min–1. Isocratic elution based on 0.1 M phosphate buffer (pH 3) - acetonitrile (70:30, v/v) with UV detection at 227 nm was applied. For the stability study separation of TIR from its degradation products was achieved using 0.1 M phosphate buffer (pH 3) - acetonitrile (72:28, v/v) with UV detection at 210 nm. Method validation parameters namely, linearity, accuracy and precision were found to be acceptable over the concentration ranges of 10-250 μg mL–1 for TIR and 1-70 μg mL–1 for TRS. The minimum detection limits were 1.76 μg mL–1 for TIR and 0.13 μg mL–1 for TRS. The optimized method was validated and proved to be specific, robust and accurate for the quality control of the cited drug in drug substance and drug product.
机译：盐酸替罗非班在ICH规定的水解（酸性和碱性降解），氧化，热和光解条件下进行降解。已经开发了一种简单而精确的液相色谱方法，并已验证了该方法可同时测定盐酸替罗非班一水合物（TIR）及其合成原料。酪氨酸（TRS）。所有色谱分离均在Zorbax SB C18、250 mm ?? 4.6 mm内径，5μm色谱柱上以1 mL min-1的流速实现。应用基于0.1 M磷酸盐缓冲液（pH 3）-乙腈（70:30，v / v）的等度洗脱，并在227 nm处进行UV检测。为了进行稳定性研究，使用0.1 M磷酸盐缓冲液（pH 3）-乙腈（72:28，v / v）进行TIR与降解产物的分离，并在210 nm处进行UV检测。方法验证参数，即线性，准确度和精密度在TIR浓度范围为10-250μgmL-1和TRS浓度范围为1-70μgmL-1范围内是可以接受的。最低检测限为TIR为1.76μgmL-1，TRS为0.13μgmL-1。验证了该优化方法的有效性，证明了该方法对原料药和药品中所引用药物的质量控制具有特异性，鲁棒性和准确性。

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