A simple, inexpensive and rapid liquid chromatography (LC) method has been developed for the quantitative determination of Lomustine, an chemotherapy drug. Degradation studies were performed on the bulk drug by heating to 60 degrees C, exposure to UV light at an energy of 200 Wh/m(2)and to visible light at an illumination of not less than 1.2 million lux hours, acid (0.1N hydrochloric acid), base (0.1N sodium hydroxide) aqueous hydrolysis and oxidation with 6.0% (v/v) hydrogen peroxide. Good resolution between the peaks corresponding to impurities produced during synthesis, degradation products and the analyte was achieved on a Symmetry C 8 LC column using a mobile phase consisting of a mixture of aqueous potassium dihydrogen phosphate and acetonitrile. The degradation samples were assayed against the reference standard of Lomustine and the mass balance in each case was close to 99.9%. Validation of the method was carried out as per International Conference on Harmonization (ICH) requirements.
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机译：已开发出一种简单，廉价且快速的液相色谱（LC）方法，用于定量测定化疗药物洛莫斯汀。通过加热至60°C，以200 Wh / m（2）的能量暴露于UV光以及以不低于120万勒克斯·小时的照度暴露于可见光，酸（0.1N盐酸（0.1N氢氧化钠）水溶液水解，并用6.0％（v / v）的过氧化氢氧化。在Symmetry C 8 LC色谱柱上，使用由磷酸二氢钾水溶液和乙腈的混合物组成的流动相，可以在对应于合成过程中产生的杂质，降解产物和分析物的峰之间实现良好的分离度。对照洛莫司汀的参考标准对降解样品进行了分析，每种情况下的质量平衡均接近99.9％。根据国际协调会议（ICH）的要求对方法进行了验证。
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