文章摘要
朱晓月,高青,朱莉娜,王雪莉,胡琴,张喆.HPLC法测定奥卡西平及其制剂中有关物质[J].中国药品标准,2023,24(2):
HPLC法测定奥卡西平及其制剂中有关物质
Determination ofthe related substances in Oxcarbazepine and its preparation by HPLC
投稿时间:2022-03-03  修订日期:2023-03-31
DOI:
中文关键词: 有关物质  奥卡西平  精神类药  高效液相色谱  梯度洗脱
英文关键词: related substances  oxcarbazepine  psychotropic drugs  HPLC  gradient elution
基金项目:
作者单位E-mail
朱晓月 北京市药品检验研究院 zhuxiaoyuebidc@163.com 
高青 北京市药品检验研究院  
朱莉娜 北京市药品检验研究院  
王雪莉 北京市药品检验研究院  
胡琴* 北京市药品检验研究院 huqin@bidc.org.cn 
张喆 北京市药品检验研究院  
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中文摘要:
      目的:建立使用C18色谱柱同时测定奥卡西平及其制剂中8个杂质的高效液相色谱法。方法:采用ACE Excel C18(4.6 mm×150 mm,3 μm)色谱柱,流速1.0 mL.min-1,以6.8 g.L-1磷酸二氢钾溶液(每1000 mL加三乙胺2 mL,用磷酸调节pH6.0)为流动相A,乙腈-甲醇(11:8)为流动相B,梯度洗脱,检测波长240 nm,柱温45 ℃。结果:奥卡西平与8个杂质分离度良好,奥卡西平和卡马西平分别在0.05~4.0 μg.mL-1和0.08~40 μg.mL-1浓度范围内呈现良好线性(r≥0.9999),奥卡西平和卡马西平的定量限为1.03 ng、0.65 ng,检测限为0.34 ng、0.33 ng。结论:本法测定奥卡西平及其制剂中的8个杂质,快速准确,灵敏度高。
英文摘要:
      Objective:To establish a HPLC method for the determination of eight related substances in oxcarbazepin and its preparation by the chromatographic column with C18. Method: The ACE Excel C18 (4.6 mm×150 mm,3 μm )was used with gradient elution at a flow rate of 1.0 mL.min-1. 6.8 g.L-1potassium dihydrogen phosphate solution (add 2mL of triethylamine in 1000 mL, and adjust to pH6.0 with phosphoric acid) was used as mobile phase A. Acetonitrile-methanol (11:8) was used as mobile phase B. The detection wavelength was 240nm. The column temperature was 45 ℃. Results: The resolution factor between the peaks complied with the related requirements. The linear ranges of oxcarbazepine and carbamazepine were 0.05-4.0 μg.mL-1 and 0.08-40 μg.mL-1 (r≥0.9999). Limit of quantitation about oxcarbazepine and carbamazepine were 1.03 ng and 0.65 ng. Limit of detection about oxcarbazepine and carbamazepine were 0.34 ng and 0.33 ng. Conclusion: The method for the determination of eight related substances in oxcarbazepin and its preparation is rapid, accurate and sensitive.
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