| 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: |
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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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