高效液相色谱法同时测定磺胺嘧啶银乳膏中磺胺嘧啶银及羟苯酯类防腐剂的含量

李洁,李婷婷

中国药学杂志 ›› 2014, Vol. 49 ›› Issue (21) : 1928-1932.

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中国药学杂志 ›› 2014, Vol. 49 ›› Issue (21) : 1928-1932. DOI: 10.11669/cpj.2014.21.016
论著

高效液相色谱法同时测定磺胺嘧啶银乳膏中磺胺嘧啶银及羟苯酯类防腐剂的含量

  • 李洁,李婷婷
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Determination of Silver Sulfadiazine and Parabens Preservatives in Silver Sulfadiazine Cream by HPLC

  • LI Jie,LI Ting-ting
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摘要

目的 建立高效液相色谱法同时测定磺胺嘧啶银乳膏中磺胺嘧啶银、羟苯甲酯、羟苯乙酯、羟苯丙酯的含量。方法 采用Agela Venusil XBP C18(L)(4.6 mm×250 mm,5 μm)色谱柱,以乙腈(A)-1%冰乙酸(B)为流动相进行梯度洗脱(0~10 min,A保持10%;10~11 min,A 10%~40%;11~23 min,A保持40%,23~24 min,A 40%~10%),流速 1.0 mLmin-1,检测波长为268 nm(磺胺嘧啶银)、257 nm(羟苯甲酯、羟苯乙酯、羟苯丙酯),柱温25 ℃。结果 磺胺嘧啶银、羟苯甲酯、羟苯乙酯、羟苯丙酯的线性范围分别为20.43~183.8 μgmL-1、5.02~75.37 μg mL-1、2.66~39.9 μg mL-1、5.01~75.17 μg mL-1(r≥0.999 5);平均回收率(n=9)分别为100.6%(RSD=0.83%),101.8%(RSD=3.2%),102.1%(RSD=3.0%),102.9%(RSD=3.3%)。结论 所建立的高效液相色谱法可同时测定磺胺嘧啶银乳膏中磺胺嘧啶银、羟苯甲酯、羟苯乙酯、羟苯丙酯的含量。

Abstract

OBJECTIVE To develop an HPLC method for the determination of silver sulfadiazine,methyl paraben,ethyl paraben, and propyl paraben in silver sulfadiazine cream. METHODS The analysis was carried out on an Agela Venusil XBP C18(L) column (4.6 mm×250 mm,5 μm). The mobile phase was composed of acetonitrile-1% glacial acetic acid with gradient elution(0-10 min,A 10%;10-11 min,A 10%-40%;11-23 min,A 40%,23-24 min,A 40%-10%)and the flow rate was 1.0 mLmin-1. The detection wavelengths were set at 268 nm for silver sulfadiazine and 257 nm for methyl paraben,ethyl paraben, and propyl paraben, respectively. The column temperature was 25 ℃. RESULTS The linear ranges of silver sulfadiazine, methyl paraben, ethyl paraben, and propyl paraben were 20.43-183.8 μgmL-1, 5.02-75.37 μgmL-1, 2.66-39.9 μg mL-1, and 5.01-75.17 μg mL-1(r≥0.999 5),respectively. The average recoveries were 100.6%,101.8%,102.1%,and 102.98%(RSD≤3.3%,n=9),respectively. CONCLUSION This method is simple and can be used to determine the above-mentioned four components with satisfactory accuracy and repeatability

关键词

磺胺嘧啶银乳膏 / 磺胺嘧啶银 / 羟苯甲酯 / 羟苯乙酯 / 羟苯丙酯 / 高效液相色谱法 / 含量测定 / 质量控制

Key words

Silver Sulfadiazine Cream / silver sulfadiazine / methyl paraben / ethyl paraben / propyl paraben / HPLC / content determination / quality control

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导出引用
李洁,李婷婷. 高效液相色谱法同时测定磺胺嘧啶银乳膏中磺胺嘧啶银及羟苯酯类防腐剂的含量[J]. 中国药学杂志, 2014, 49(21): 1928-1932 https://doi.org/10.11669/cpj.2014.21.016
LI Jie,LI Ting-ting. Determination of Silver Sulfadiazine and Parabens Preservatives in Silver Sulfadiazine Cream by HPLC[J]. Chinese Pharmaceutical Journal, 2014, 49(21): 1928-1932 https://doi.org/10.11669/cpj.2014.21.016
中图分类号: R917   

参考文献

[1] Ch. P(2010) Vol Ⅱ(中国药典2010年版. 二部)[S]. 2010:1146-1147.[2] USP 36-NF 31 [S]. 2013.[3] KANG L H,ZHONG H M. HPLC Assay for silver sulfadiazine in silver sulfadiazine cream[J].Acad J Guangdong Coll Pharm (广东药学院学报),2006,22(3):287-288.[4] LI Y L,ZHENG Q K,HUANG Z J. Determination of the content and the related substances of silver sulfadiazine gel by HPLC[J]. Chin J Hosp Pharm(中国医院药学杂志),2004,24(8):474-475.[5] WU J Y,WANG Z Q,HUANG X S. Comparision of two methods for the content determination of sulfadiazine silver embrocation[J]. Strait Pharm J(海峡药学),2010,22(3):41-43.
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