| 刘晓玲,杨丽娜,倪晓霞,等.高效液相色谱法测定盐酸丁卡因注射液中盐酸丁卡因的含量及有关物质[J].安徽医药,2016,20(9):1658-1660. |
| 高效液相色谱法测定盐酸丁卡因注射液中盐酸丁卡因的含量及有关物质 |
| Determination of tetracaine hydrochloride and the related substances in Tetracaine Hydrochloride Injection by HPLC |
| 投稿时间：2016-03-05 |
| DOI： |
| 中文关键词: 丁卡因/分析 色谱法,高压液相 |
| 英文关键词: |
| 基金项目: |
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| 摘要点击次数: 2300 |
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| 中文摘要: |
| 目的 建立高效液相色谱法测定盐酸丁卡因注射液中盐酸丁卡因含量及有关物质检查的方法。方法 采用高效液相色谱法,色谱柱为Agilent ZORBAX SB-C18柱(250 mm×4.6 mm,5 μm),流动相A和B为0.05 mol·L-1磷酸二氢钾溶液[用稀磷酸或三乙胺调节pH值至(3.0±0.1)]和甲醇(70∶30),梯度洗脱,流速为1.0 mL·min-1,柱温30 °C,盐酸丁卡因含量测定检测波长310 nm,有关物质检测波长为280 nm,进样量为20 μL。结果 盐酸丁卡因在10.0～100.0 mg·L-1范围内线性良好(r=0.999 9),平均回收率为98.73%,RSD值为0.72%(n=9)。结论 该方法精密度高、准确可靠,可用于盐酸丁卡因注射液质量控制。 |
| 英文摘要: |
| Objective To establish an HPLC method for determining the content of tetracaine hydrochloride and the related substances in Tetracaine Hydrochloride Injection.Methods HPLC was used.The analytical column was Agilent ZORBAX SB-C18(5 μm,4.6×250 mm),0.05 mol·L-1 potassium dihydrogen phosphate solution[adjusted with phosphoric acid or triethylanune to pH(3.0±0.1)]and methanol(70∶30) were adopted as mobile phase using gradient elution with the flow rate of 1.0 mL·min-1.The detection wavelength was 310 nm for tetracaine hydrochloride,and 280 nm for the related substances.The column temperature was 30°C and the injection volume was 20 μL.Results The good linear relationship of tetracaine hydrochloride ranged from 10.0 to 100.0 mg·L-1 (r=0.999 9),and the average recovery was 98.73% with theRSD of 0.72%(n=9).Conclusions The method is reliable,accurate and can be used for the quality control of Tetracaine Hydrochloride Injection. |
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