测定药物中的痕量杂质

Determination of Impurity in Drugs Using On-line Concentration Technique in CTAB Buffer Solution

利用在线富集技术测定药物佐米曲坦和盐酸美西律中的痕量杂质.比较了分别在十六烷基三甲基溴化铵(CTAB)和十二烷基磺酸钠(SDS)存在下在线富集的效果,考察了CTAB浓度、进样时间、缓冲液pH值对富集的影响.结果表明:利用SDS富集会出现假峰现象,而在CTAB改向条件下能得到较好的富集效果,其优化条件为15mmol/LNa2B4O7+1.0mmol/LCTAB(pH=9.18),进样时间100s.方法可行,准确度好.

An on-line concentration technique was developed to determinate trace impurity in Zolmitriptan and Mexitil.The experiment compared the effect of concentration in CTAB and SDS buffer solution.The effect of CTAB concentration,the injection time,pH value of buffer on the concentration was investigated.False peaks appeared when sample injection was long and SDS concentration was high,but satisfactory concentration could be gained in CTAB buffer solution.It had been proved that the optimum concentration buffer solution was 15?mmol/L Na_2B_4O_7+1.0?mmol/L CTAB(pH=9.18) and the optimum injection time was 100?s.The method is feasible and accurate.