| 焦旭雯,梁蔚阳,陈华.HPLC梯度洗脱法测定丙泊酚中/长链脂肪乳注射液的含量及有关物质[J].中国药品标准,2016,17(5):347-353 |
| HPLC梯度洗脱法测定丙泊酚中/长链脂肪乳注射液的含量及有关物质 |
| Determination of the Content and Related Substances for Propofol Medium and Long Chain Fat Emulsion Injection by HPLC Gradient Elution |
| 投稿时间：2016-07-16 修订日期：2016-09-09 |
| DOI： |
| 中文关键词: 高效液相色谱法 丙泊酚 有关物质 含量测定 |
| 英文关键词: HPLC propofol related substance quantitative determination |
| 基金项目:广东省食品药品检验检测技术创新专项资金项目（2015ZX05）；广东省医学科学技术研究基金项目（B2016106） |
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| 中文摘要: |
| 目的：建立测定丙泊酚中/长链脂肪乳注射液中的丙泊酚及其有关物质的HPLC方法。方法：色谱柱为Waters XBridge RP18柱（4.6mm×150mm，5μm）；流动相为磷酸二氢钠溶液-乙腈，梯度洗脱；柱温为40℃；检测波长为275nm和254nm。丙泊酚的测定采用外标法，有关物质检查采用外标法与自身对照法。结果：丙泊酚与其两杂质能较好分离，相邻各峰间分离度均大于1.5；丙泊酚、杂质Ⅰ和杂质Ⅱ的线性范围分别为97.2~1457.9μg?mL-1（r=0.999 9）、0.11～1.57μg?mL-1（r=0.999 9）和0.11～1.59μg?mL-1（r=0.999 9）；平均回收率（n=9）分别为99.2%（RSD＝1.4%）、105.8%（RSD＝1.5%）和96.7%（RSD＝4.8%）。结论：所建方法简便快速、专属性强、重复性好，可用于丙泊酚中/长链脂肪乳注射液的含量测定和杂质检查。 |
| 英文摘要: |
| Objective: To develop an HPLC method for the determination of Propofol and its related substances in Propofol Medium and Long Chain Fat Emulsion Injection . Methods: A Waters XBridge RP18 column (4.6mm×150mm, 5μm) was adopted with sodium dihydrogen phosphate solution – acetonitrile as mobile phase, gradient elution. The column temperature was set at 40℃ and the detection wavelengths were 275 nm and 254nm . Propofol was determined by external standard method and the related substances were determined by external standard method and main component self-control method. Results: Complete separation was achieved for Propofol and two impurities with a resolution of greater than 1.5 between the neighbour peaks. The linear ranges were 97.2–1457.9μg?mL-1（r=0.999 9）for Propofol, 0.11–1.57μg?mL-1（r=0.999 9）for impurity Ⅰand 0.11–1.59μg?mL-1（r=0.999 9）for impurity Ⅱ, respectively. The average recoveries for Propofol, impurity Ⅰ and impurity Ⅱ were 99.2%, 105.8% and 96.7%with RSD of 1.4%, 1.5% and 4.8%, respectively. Conclusion: The method is simple, rapid, specific and reproducible, which is practicable for the determination and impurity test of Propofol Medium and Long Chain Fat Emulsion Injection |
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