Pathare D B, Jadhav A S, Shingare M S
Department of Chemistry, Dr. B.A. Marathawada University, Aurangabad 431004, India.
J Pharm Biomed Anal. 2007 Apr 11;43(5):1825-30. doi: 10.1016/j.jpba.2006.12.002. Epub 2007 Jan 12.
The present paper describes the development of a stability indicating reversed phase liquid chromatographic (RPLC) method for oxcarbazepine in the presence of its impurities and degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of oxcarbazepine was observed under base hydrolysis. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from the synthetic impurities and degradation product formed under stress conditions was achieved on a C18 column using mixture of aqueous 0.02 M potassium dihydrogen phosphate-acetonitrile-methanol (45:35:20, v/v/v) as mobile phase. The developed HPLC method was validated with respect to linearity, accuracy, precision, specificity and robustness. The developed HPLC method to determine the related substances and assay determination of oxcarbazepine can be used to evaluate the quality of regular production samples. It can be also used to test the stability samples of oxcarbazepine.
本文描述了一种稳定性指示反相液相色谱（RPLC）方法的开发，该方法用于在杂质存在以及强制降解研究产生的降解产物存在的情况下测定奥卡西平。原料药经受了水解、氧化、光解和热降解等强制条件。在碱性水解条件下观察到了奥卡西平的降解。发现该药物对尝试的其他强制条件稳定。使用0.02 M磷酸二氢钾水溶液 - 乙腈 - 甲醇（45:35:20，v/v/v）的混合物作为流动相，在C18柱上成功实现了药物与合成杂质以及在强制条件下形成的降解产物的分离。所开发的高效液相色谱法在线性、准确度、精密度、特异性和稳健性方面进行了验证。所开发的用于测定奥卡西平相关物质和含量测定的高效液相色谱法可用于评估常规生产样品的质量。它也可用于测试奥卡西平的稳定性样品。
