| 引用本文: | 姬莉芳,李清,毕开顺,戴雯静,韩笑,何淑旺.妥洛特罗原料药含量测定方法的比较[J].中国现代应用药学,2014,31(12):1493-1496. |
| JI Lifang,LI Qing,BI Kaishun,DAI Wenjing,HAN Xiao,HE Shuwang.Comparison of Determination Methods for Tulobuterol[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(12):1493-1496. |
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| 摘要: |
| 目的 研究妥洛特罗原料药的含量测定方法。方法 非水滴定法以冰醋酸-醋酐(7∶3)为溶剂，结晶紫为指示液，用高氯酸滴定液(0.1 mol·L-1)滴定，以电位法来判定滴定终点，并将指示液在电位突跃时的颜色作为滴定终点颜色；高效液相色谱法采用C18(250 mm×4.6 mm，5 μm)色谱柱，乙腈-5 mmol·L-1磷酸二氢钾缓冲液(25∶75)作为流动相，检测波长为215 nm。结果 非水滴定法与高效液相色谱法测定结果差异无统计学意义。结论 非水滴定法和高效液相色谱法均能有效地控制本品的含量，为妥洛特罗原料药的质量控制提供科学依据。 |
| 关键词: 妥洛特罗 含量测定 非水滴定 高效液相色谱法 |
| DOI： |
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| 基金项目:国家“重大新药创制”科技重大专项(2009ZX09301-012) |
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| Comparison of Determination Methods for Tulobuterol |
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JI Lifang1, LI Qing1, BI Kaishun1, DAI Wenjing1, HAN Xiao1, HE Shuwang2
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1.Shenyang Pharmaceutical University, Shenyang 110016, China;2.Shandong Dyne Marine Organism Pharmaceutical Stock Co., Ltd., Beijing 100025, China
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| Abstract: |
| OBJECTIVE To compare two methods for the determination of tulobuterol. METHODS Non-aqueous titration method was performed with acetic acid and acetic anhydride(7∶3) as the solvent and crystal violet as indicator. The tulobuterol solution was titrated with 0.1 mol·L-1 perchloric acid solution. The end point was decided by potentiometric method and indicator method. The HPLC method was performed on a C18 column(250 mm×4.6 mm, 5 μm) with mobile phase of acetonitrile-5 mmol·L-1 phosphate buffer at flow-rate of 1 mL·min-1. The detection was conducted at 215 nm. RESULTS There was no significant difference in accuracy between the results of HPLC and the nonaqueous titration method. CONCLUSION The results indicated that the two methods were simple, accurate and reproducible, and they both can be used to determine the content of tulobuterol. |
| Key words: tulobuterol determination non-aqueous titration HPLC |
