| 李琳 郑志兵 高立军 杨茜 刘松华 全东琴△.高效液相色谱法测定1,25- 二羟基维生素D2纳米乳注射液的含量[J].,2016,16(17):3223-3226 |
| 高效液相色谱法测定1,25- 二羟基维生素D2纳米乳注射液的含量 |
| Determination of Content for 1,25-dihydroxyvitamin D2 NanoemulsionInjections by High Liquid Chromatography (HPLC) |
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| DOI： |
| 中文关键词: 1,25-二羟基维生素D2 高效液相色谱法 含量测定 纳米乳注射液 |
| 英文关键词: 1,25-dihydroxyvitamin D2 HPLC Content determination Nanoemulsion injections |
| 基金项目:国家自然科学基金项目（81102390） |
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| 中文摘要: |
| 目的：建立高效液相色谱法测定1,25- 二羟基维生素D2纳米乳注射液含量。方法：采用C18-STⅡ色谱柱（4.6 × 250 mm，5
滋m）；流动相为乙腈- 水=85：15（V/V）；流速：1.5 mL/min；检测波长：274 nm；温度：室温；进样量：200 滋L。结果：该方法专属性好，
平均回收率99.96%（RSD 为0.63% ，n=9）；溶液在冷藏（2 ~ 6℃）保存24 h稳定（RSD=0.98%，n=7）；在0.06 滋g/mL ~ 4.0 滋g/mL范
围内线性关系良好，其回归方程为：Y = 201098X - 8412.5（R2=0.9998，n=9）。结论：该方法简便、快捷、灵敏度高、专属性强，可用于
该注射液的含量测定。 |
| 英文摘要: |
| Objective:To establish a method for determination of the content in 1,25-dihydroxyvitamin D2 nanoemulsion injections
by high performance liquid chromatography (HPLC).Methods:Chromatographic column was C18-STⅡ column (4.6× 250 mm, 5
um). The mobile phase was acetonitrile: water 85:15 (V/V), with a flow rate of 1.5 mL/min. The detection wavelength was 274 nm and
the injection volume was 200 uL.Results:The calibration curves showed good linearity (R2=0.9995, n=5) within ranges of 0.06 ~ 4.0
ug/mL. The average recovery of the method was about 99.96%(RSD = 0.63%, n=9) and the stability under 2 ~ 6℃ was acceptable in 24
h (RSD=0.98%, n=7).Conclusion:The validated method is shown to be reproducible, accurate, sensitive and selective. The results indicated
that the developed method could be readily utilized as a method for determination of the title nanoemulsion injections. |
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