摘要
目的建立HPLC法测定注射用比阿培南的含量,并考察其与0.9%氯化钠、5%葡萄糖、10%葡萄糖、葡萄糖氯化钠、复方氯化钠注射液配伍的稳定性。方法采用色谱柱Symmetry C18（4.6×150mm,5μm）、流动相为醋酸盐缓冲液∶乙腈（100∶3,v/v）、检测波长294nm;在25℃、室内自然光照射下观察配伍液的外观变化,同时监测配伍液pH值及比阿培南含量的变化。结果比阿培南线性范围0.01~1.0mg.mL-1,r=0.9998（n=8）;平均回收率99.57%,RSD 1.30%,最低定量限58ng.mL-1（S/N≥10）。在0.9%氯化钠注射液、5%葡萄糖注射液中10h,葡萄糖氯化钠注射液中8h,10%葡萄糖注射液中5h,比阿培南的含量变化均〈5%;在复方氯化钠注射液中,3h时比阿培南的含量即小于95%。5种配伍液pH值均略降低,但24h内皆未超出药典规定范围。葡萄糖氯化钠配伍液6h起,10%葡萄糖配伍液10h起,颜色开始逐渐变黄加深。结论在25°C室内自然光照射下,比阿培南可与除复方氯化钠以外的本文其他4种输液配伍使用,但须注意稳定时间有所差别。本文建立的HPLC法适用于比阿培南含量测定。
OBJECTIVE To establish an HPLC method for determination of Biapenem and investigate its stability in five infusion solutions（0.9%Sodium Chloride injection;5%、10%Glucose injection;Glucose and Sodium Chloride injection,Compound Sodium Chloride Injection）.METHODS Symmetry C18（4.6×150mm,5μm）column was used,the mobile phase was acetate buffer：Methyl Cyanides（100∶3,v/v）,UV detection was at 294nm,the content of Biapenem was detected regularly after being dissolved in the five different infusion solutions within 24h at 25℃、exposure to natural light at the same time.the external appearance and pH value were observed synchronously.RESULTS Biapenem was linear over the range of 0.01～1.0mg·mL-1,r=0.9998（n=8）,the average recovery was 99.57%（RSD=1.30%）,The lowest detectable concentration for Biapenem was 58ng·mL-1（S/N≥10）.The degradation of Biapenem was less than 5%in 0.9%Sodium Chloride injection or 5%Glucose injection within 10h,the time was 8h and 5h in Glucose and Sodium Chloride injection and 10%Glucose injection respectively.Biapenem degraded more than 5%in Compound Sodium Chloride Injection within 3h.The pH value declined slightly in all the compatible solutions within 24h,but the values lied in the approved range of pharmacopoeias.The color of the compatible solutions were yellow discoloration from 6h or 10h in Glucose and Sodium Chloride injection or 10%Glucose injection respectively.CONCLUSION Biapenem could be dissolved in 0.9%Sodium Chloride injection,5%、10%Glucose injection,Glucose and Sodium Chloride injection,but the settling time were different.Biapenem was not stabile in Compound Sodium Chloride Injection.The HPLC method was suitable for Biapenem assaying.
出处
《海峡药学》
2011年第9期44-46,共3页
Strait Pharmaceutical Journal
