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首页> 外文期刊>American Journal of Analytical Chemistry >Development and Validation of Stability Indicating LC Method for 10-Hydroxycamptothecin
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Development and Validation of Stability Indicating LC Method for 10-Hydroxycamptothecin

机译：10-羟基喜树碱稳定性指示LC方法的建立与验证

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摘要

The present method gives a detailed description for the development and validation of a simple stability indicating reverse phase liquid chromatographic method for 10-hydroxycamptothecin(10-HCTN) in the presence of its impurities namely Imp A and Imp B along with degradation products generated from forced degradation studies. The drug was subjected to stress conditions of hydrolysis (acid, base and neutral), oxidative, photolytic and thermal stress degradation. Degradation was observed when subjected to treatment with peroxides or under conditions normally used for typical acid and base hydrolysis. The drug was found to be stable under other stress conditions attempted such as photolytic and thermal. Successful separation and isolation of the drug from related impurities and degradation products formed under stress conditions was achieved on an Inertsil ODS-3V (250 mm × 4.6 mm, 5 μm) column using a phosphate buffer, acetonitrile, methanol and Nanopure water. The developed HPLC method was validated with respect to specificity, linearity, accuracy, precision, sensitivity, robustness and solution stability. The assay method was found to be linear in the range of 0.16 mg/mL to 0.24 mg/mL with a correlation coefficient of 0.999 and the linearity of the impurities was established from 0.02% (LOQ) to 0.3%. Recoveries of assay and impurities were found between 99.4% and 100.3%. The developed HPLC method can be used to determine the related substances and assay determinations of 10-HCTN and also to evaluate the quality and long term stability of production samples.
机译：本方法给出了开发和验证简单稳定性的详细说明，该稳定性表明在杂质（即Imp A和Imp B）以及由强制产生的降解产物的存在下10-羟基喜树碱（10-HCTN）的反相液相色谱方法退化研究。该药物受到水解（酸，碱和中性），氧化，光解和热应力降解的胁迫条件。当用过氧化物处理或在通常用于典型的酸和碱水解的条件下观察到降解。发现该药物在尝试过的其他应激条件下（如光解和热）稳定。使用磷酸盐缓冲液，乙腈，甲醇和纳米纯水在Inertsil ODS-3V（250 mm×4.6 mm，5μm）色谱柱上成功地将药物与应力条件下形成的相关杂质和降解产物分离和分离。所开发的HPLC方法在特异性，线性，准确性，精密度，灵敏度，稳健性和溶液稳定性方面得到了验证。发现该测定方法在0.16 mg / mL至0.24 mg / mL的范围内呈线性，相关系数为0.999，杂质的线性从0.02％（LOQ）至0.3％。测定和杂质的回收率在99.4％至100.3％之间。所开发的HPLC方法可用于确定10-HCTN的相关物质和含量测定，还可用于评估生产样品的质量和长期稳定性。

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