论文部分内容阅读
目的采用高效液相色谱法测定盐酸吉西他滨溶液中的有关物质,通过杂质量变化考察盐酸吉西他滨的稳定性。方法采用HPLC测定盐酸吉西他滨有关物质的量,考察了各破坏条件下以及室温放置对盐酸吉西他滨稳定性的影响。结果盐酸吉西他滨在各破坏条件下均主要检出杂质Z2;盐酸吉西他滨溶液在室温放置过程中,Z2的量随时间成比例增加,24 h时该杂质增加的量已经超过质量标准的20%(0.02%)。结论盐酸吉西他滨原料药在某些破坏条件下和溶液在室温放置过程中,杂质Z2增加明显,表明盐酸吉西他滨溶液不稳定。建立方法的专属性、线性等均良好,能用于原料药及其制剂中有关杂质检测。
Objective To determine the related substances in gemcitabine hydrochloride solution by high performance liquid chromatography (HPLC) and determine the stability of gemcitabine hydrochloride by the change of impurity. Methods The amount of gemcitabine hydrochloride related substances was determined by HPLC. The effects of gemcitabine hydrochloride on the stability of gemcitabine hydrochloride were investigated under various destructive conditions and at room temperature. Results Gemcitabine hydrochloride mainly detected the impurity Z2 under each destructive condition. During the process of placing gemcitabine hydrochloride solution at room temperature, the amount of Z2 increased proportionally with time, and the increase amount of this impurity exceeded 20% of the quality standard at 24 h (0.02 %). Conclusion Gemcitabine hydrochloride API can increase the impurity Z2 significantly under some destructive conditions and when the solution is left at room temperature, indicating that the gemcitabine hydrochloride solution is unstable. The establishment of the method of specificity, linear, etc. are good, can be used for API and its agents in the detection of impurities.