摘要
目的 考察不同的氨基糖苷类抗生素在蒸发光散射检测器中的响应因子是否一致 ,进而考察ELSD在该类药的有关物质检查、多组分同类物质的相对比例测定及氨基糖苷类新药基准品的建立等方面应用的可能性。方法 用HPLC ELSD法测定了一组氨基糖苷类抗生素 (阿米卡星、西索米星、奈替米星、依替米星和一类新药威替米星 )的线性方程。色谱条件 :DiamonsilC1 8柱 15 0mm× 4 6mm ,5 μm ;流动相 0 2 mol·L- 1 三氟醋酸 甲醇 (94∶6 ) ;流速0 6mL·min- 1 。检测器条件 :漂移管温度 110℃ ,气体流速 2 80L·min- 1 。结果 上述 5种物质的线性方程间无显著性差异 (P >0 0 5 )。结论 5种不同氨基糖苷类抗生素在蒸发光散射检测器中的响应因子一致 ,可以尝试用HPLC ELSD法测定该类药中的有关物质、控制多组分药物的相对比例并建立一类新药基准品。
AIM To analyze if the response factors of different aminoglycoside antibiotics detected by evaporative light-scattering detector (ELSD) are the same. If they are, then ELSD can be applied to the quality analysis of this class of antibiotics. METHODS The response factors of five different aminoglycosides (amikacin, sisomicin, netilmicin, etimicin and vertilmicin) detected by ELSD were determined by using a Diamonsil C 18 column (150 mm×4 6 mm, 5 μm) as analytical column and 0 2 mol·L -1 trifluoroacetic acid-methanol (94∶6) as mobile phase at a flow rate of 0 6 mL·min -1 , the temperature of the drift tube was set at 110℃, and the flow of carrier gas at 2 80 L·min -1 . Detector responses ( A ) and the amount of injection of each substance ( m ) were fitted to the logarithmic regression: log A = b log m +log a . RESULTS The linear regression equation obtained were: amikacin: Y =1 46 X +5 07, γ=0 9997; sisomicin: Y =1 51 X +5 03, γ=0 9997; netilmicin: Y =1 52 X +4 88, γ=1 000; etimicin: Y =1 46 X +4 85, γ=0 9999; vertilmicin: Y =1 41 X +4 90, γ=0 9998. The differences between them were negligible. CONCLUSION Different aminoglycosides can give the same responses with ELSD detection. So, the HPLC-ELSD methods can be applied to the analysis of impurities, the control of the ratio of multi-components drug and the determination of new substances by using another substance as reference, etc.
出处
《药学学报》
CAS
CSCD
北大核心
2002年第3期204-206,共3页
Acta Pharmaceutica Sinica
