Validated HPLC-RI Method for the Determination of Lactulose and its Process Related Impurities in Syrup

A simple, swift with good sensitivity and reproducibility, HPLC-RI method has been developed for the quantification of lactulose and related compounds (fructose, galactose, epilactose and lactose) in oral suspension formulation. The analysis was carried out by using mobile phase (water and acetonitrile 75:25) at the flow rate of 1.0 ml/min. on isocratic HPLC-RI system. After manipulating mobile phase composition and mobile phase flow rate a good separation of five components was achieved within 15 minutes of run time. This study is beneficial to determine the active ingredient as well as related compounds simultaneously, without using buffer in mobile phase which causes bad resolution and has limitation to analyze on other hyphenated techniques such as LC-MS.     

注射用阿洛西林钠在5%木糖醇注射液中的稳定性考察

目的研究注射用阿洛西林钠在5%木糖醇注射液中的稳定性。方法用高效液相色谱法测定阿洛西林钠的含量,用经典恒温加速法和多元线性模型研究温度对阿洛西林钠在5%木糖醇注射液中稳定性的影响。结果各温度下阿洛西林钠百分含量的对数（lgC）与时间（t）具有线性关系,符合一级动力学反应。用经典恒温加速法和多元线性模型预测阿洛西林钠在5%木糖醇注射液的有效期分别为5.09d,5.59d。结论2种方法预测得到的有效期基本一致。在25℃,注射用阿洛西林钠在5%木糖醇注射液应在5d内稳定。