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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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盐酸克林霉素棕榈酸酯含量测定方法的改进研究

Improved method for determination of clindamycin palmitate hydrochloride

分类号:R917
出版年·卷·期(页码):2020,40 (4):717-721
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 建立HPLC-UV法测定盐酸克林霉素棕榈酸酯的含量。方法: 采用Waters Symmetry C8(4.6mm×250 mm,5 μm)色谱柱,以0.005 mol·L-1醋酸铵溶液-乙腈(10:90)为流动相,流速1.0 mL·min-1,检测波长为230 nm。结果: 克林霉素棕榈酸酯质量浓度在0.2~4.0 mg·mL-1范围内线性关系良好(r=1.000);平均回收率(n=3)为100.3%~102.0%,RSD为0.33%~0.72%;3批样品中盐酸克林霉素棕榈酸酯的含量分别为58.76%、58.56%、58.33%。结论: 该方法可作为盐酸克林霉素棕榈酸酯的定量分析方法。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish an HPLC-UV method for determination of clindamycin palmitate hydrochloride.Methods: Waters Symmetry C8 column(4.6 mm×250 mm,5 μm)was used.The mobile phase consisted of 0.005 mol·L-1 ammonium acetate and acetonitrile(10:90)at the flow rate of 1.0 mL·min-1,and the UV detection wavelength was 230 nm.Results: The good liner range of clindamycin palmitate was obtained between 0.2-4.0 mg·mL-1(r=1.000).The average recovery rate(n=3)was 100.3%-102.0% with RSD of 0.33%-0.72%.The contents of clindamycin palmitate hydrochloride in three batches were 58.76%,58.56%,58.33%,respectively.Conclusion: This established HPLC-UV method can be used as a quantitative analysis method for clindamycin palmitate hydrochloride drug substance.

-----参考文献:---------------------------------------------------------------------------------------
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