HPLC法测定氟哌利多注射液的有关物质及含量___
RP-HPLC determination of the contents of droperidol injection and its related substances
分类号：
出版年·卷·期（页码）：2009,29 (4):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
摘要 目的：建立RP-HPLC法测定氟哌利多注射液的有关物质及含量的检测方法。方法：采用Diamonsil C18(150 mm×4.6 mm，5 μm) 色谱柱，流动相为水-乙腈-三乙胺（70：30：0.9），醋酸调pH至5.9，流速：1.0 mL•min-1，检测波长：275nm，柱温：35℃。结果：氟哌利多的线性范围为50～150 μg•mL-1，相关系数为：0.9996。回收率(n=9)为100.8%。结论：该方法简便准确，重复性好，可为控制氟哌利多注射液的含量和有关物质的质量标准提供参考。
-----英文摘要：---------------------------------------------------------------------------------------
Abstract Objective: To establish an RP-HPLC method to determine the contents of droperidol injection and its related substances. Methods: The contents of injectio droperidoli was measured by RP-HPLC with a column of Diamonsil C18(150 mm×4.6 mm,5 μm), water-acetonitrile-triethylamine（70：30：0.9）,adjust the pH to 5.9 with acetic acid as mobile phase,the flow rate was 1.0 mL•min-1, the detection wavelengths was 275 nm, the column temperature was 35 ℃.Results: The calibration curves showed good linearity in the range of 50-150 μg•mL-1,correlation coefficients was 0.9996. The average recoveries (n=9) was 100.8%.Conclusion: An accurate and reproducible method can be used for the quality control of injectio droperidoli.
-----参考文献：---------------------------------------------------------------------------------------
1. Drug Specification Promulgated by the ministry of Public Health,PR China.Part2,Vol.4, (卫生部药品标准二部第四册)：1996:70，71
2. BP.2007:749,2539
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