| 摘要: |
| 目的:建立高效液相色谱(HPLC)法测定氟哌噻吨美利曲辛片有效成分的含量并控制杂质。方法:色谱柱为C18(150 mm×4.6 mm,5 μm);流动相为甲醇鄄0郾2%磷酸(含0.1%三乙胺)(65 ∶35);流速1.0 mL/ min,柱温30 ℃,检测波长257 nm,进样量20 μL。结果:美利曲辛测得含量为标示量的98.89%,线性浓度范围20 ~240 μg/ mL,低、中、高浓度供试品的平均回收率分别为102.8%、99.5%、99.5%;氟哌噻吨测得含量为标示量的96.17%,线性浓度范围10 ~100 μg/ mL,低、中、高浓度供试品的平均回收率分别为100.1%、101.8%、100.2%。杂质总量与美利曲辛含量的百分比<1.0%。结论:该方法灵敏、准确、专属性强,可用于氟哌噻吨美利曲辛片的质量控制。 |
| 关键词: 氟哌噻吨 美利曲辛 含量测定 质量标准 高效液相色谱 |
| DOI： |
| 投稿时间：2017-05-10修订日期：2017-06-28 |
| 基金项目: |
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| Active Constituent Content of Flupentixol Melitracen Tablets Detected by HPLC |
| Xu jing,Guo Fang,Song Dan,Guan haiyan |
| (Department of Pharmacy,Institute of Surgery Research,Daping Hospital,Third Military Medical University;School of Pharmacy,Chongqing Medical University;Chongqing technical center for drug evaluation & certification) |
| Abstract: |
| Objective: To develop a HPLC method to determinate the active constituent content of flupentixol melitracen tablet.Methods: Diamonsil technology C18 column (150 mm×4.6 mm, 5 μm) was used with methanol-0.2% phosphoric acid (including 0.1% triethylamine) (65 ∶35) as the mobile phase at a flow rate of 1.0 mL/ min. Column temperature was 30 ℃. Detected wavelength was 257 nm. Results: Melitracen content was 98.89%, linear range was 20 ~240 μg/ mL, the average recoverys of low, middle and high concentration were 102.8%, 99.5%, 99.5%. Flupentixol content was 96.17%, linear range was 10 ~100 μg/ mL, the average recoverys of low, middle and high concentration were 100.1%, 101.8%, 100.2%. The impurity amount in melitraven was not greater than 1.0%. Conclusion: The results demonstrated this method is sensitive, accurate, precise and specific for the determination of the contents and relative substances. It is useful for the quality control of flupentixol melitracen tablet. |
| Key words: flupentixol melitracen content determination quality standard HPLC |
