摘要
目的:建立注射用雷替曲塞的质量控制方法。方法:进行注射用雷替曲塞的性状、鉴别等质量研究,用高效液相色谱法测定其含量及有关物质;采用影响因素试验、加速试验和长期试验考察其稳定性。结果:雷替曲塞浓度在0.165~333.0mg·L-1范围内呈良好线性关系,平均回收率为100.0%(RSD=1.20%)。样品稳定性考察除高温(60±2)℃及强光(4500±500)Lx条件外,其他条件下的各项指标均无明显变化。结论:注射用雷替曲塞质量可控,应贮存于阴凉、避光处。
OBJECTIVE To establish a quality control method for raltitrexed for injection. METHODS The quality of raltitrexed for injection,such as properties, identification, was studied. HPLC was used to determine raltitrexed content and its related compounds. The stability of the samples was tested by forced degradation, accelerated and long-term experiments. RENULTS Rahitrexed showed good linear relationship in the range of 0. 165-333. 0 mg·L^-1. The average recovery of rahitrexed was 100. 0-(RSD= 1.20%). The injection was stable except to heat (60 ± 2)℃ and strong light (4 500 ± 500)Lx. CONCLUSION The quality of rahitrexed for injection is controllable. The injection should be kept in a cool and dark place.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2009年第12期1003-1005,共3页
Chinese Journal of Hospital Pharmacy