摘要
研究了注射用帕米膦酸二钠的稳定性。考察了在极端条件下本品的降解情况以及强光、高温和高湿等因素对帕米膦酸二钠注射液稳定性的影响,并对帕米膦酸二钠注射液进行加速试验考察。采用HPLC法,色谱柱为C18,流动相为乙腈∶0.4%EDTA的氢氧化钠溶液=21∶79;检测波长:激发光谱为395nm,发射光谱为480nm。本品经强光、高温和高湿、加速试验考察后各项指标均符合质量标准的规定。本方法灵敏度高,专属性强,是进行稳定性研究的可靠方法。
The stability of pamidronate disodium injection was studied by HPLC with C18 column,acetonitrile and the sodium hydroxide solution of 0.4% EDTA（21 ： 79） as mobile phase,and excitation wavelength of 395nm and emission wavelength of 480nm. The results show the injection was rather stable after exposure to strong light, high temperature and high humidity under stress-testing condition. The HPLC method was used for quality control and stability testing of pamidronate disodium injection with high sensitivity and specificity.
出处
《光谱实验室》
CAS
CSCD
2006年第2期183-186,共4页
Chinese Journal of Spectroscopy Laboratory
