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用于同时分析固定剂量复方片剂中拉米夫定和齐多夫定的正相高效薄层色谱法的开发与验证

Development and validation of a normal-phase HPTLC method for the simultaneous analysis of Lamivudine and Zidovudine in fixed-dose combination tablets.

作者信息

Venkatesh Palani, Daggumati Mahesh

机构信息

Mother Theresa Post Graduate and Research Institute of Health Sciences, Pondicherry University, Pondicherry 605006, India.

KMCH College of Pharmacy, Kovai Estate, Kalapatti Road, Coimbatore 641048, India.

出版信息

J Pharm Anal. 2012 Apr;2(2):152-155. doi: 10.1016/j.jpha.2011.11.002. Epub 2011 Nov 10.

DOI:10.1016/j.jpha.2011.11.002
PMID:29403735
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5760830/
Abstract

Simultaneous quantification of Lamivudine and Zidovudine in tablets by HPTLC method was developed and validated. The chromatograms were developed using a mobile phase of toluene:ethyl acetate:methanol (4:4:2, v/v/v) on pre-coated plate of silica gel GF aluminum TLC plate and quantified by densitometric absorbance mode at 276 nm. The values were 0.41±0.03 and 0.60±0.04 for Lamivudine and Zidovudine, respectively. The linearity of the method was found to be within the concentration range of 50-250 ng/spot for Lamivudine and for Zidovudine, it was 100-500 ng/spot. The lower limits of detection and quantification were 2.23 ng/spot and 7.90 ng/spot for Lamivudine and 2.90 ng/spot and 8.85 ng/spot for Zidovudine. The method was also validated for precision, specificity and recovery. This developed method was used to analyze fixed-dose tablets (Duovir, Cipla Ltd) samples of Lamivudine and Zidovudine.

摘要

采用高效薄层色谱法(HPTLC)同时测定片剂中拉米夫定和齐多夫定的含量,并进行了方法验证。在硅胶GF铝预涂薄层板上,以甲苯∶乙酸乙酯∶甲醇(4∶4∶2,v/v/v)为流动相展开色谱图,于276 nm波长处采用密度计吸光度模式进行定量分析。拉米夫定和齐多夫定的比移值(Rf)分别为0.41±0.03和0.60±0.04。该方法的线性范围为:拉米夫定50 - 250 ng/点,齐多夫定100 - 500 ng/点。拉米夫定的检测限和定量下限分别为2.23 ng/点和7.90 ng/点,齐多夫定的检测限和定量下限分别为2.90 ng/点和8.85 ng/点。对该方法的精密度、特异性和回收率也进行了验证。所建立的方法用于分析拉米夫定和齐多夫定的复方制剂(双汰芝,西普拉有限公司)样品。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0c7/5760830/3ba7f23d685d/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0c7/5760830/fedd36c31503/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0c7/5760830/3ba7f23d685d/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0c7/5760830/fedd36c31503/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0c7/5760830/3ba7f23d685d/gr2.jpg

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本文引用的文献

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Simultaneous measurement of intracellular triphosphate metabolites of zidovudine, lamivudine and abacavir (carbovir) in human peripheral blood mononuclear cells by combined anion exchange solid phase extraction and LC-MS/MS.通过组合阴离子交换固相萃取和液相色谱-串联质谱法同时测定人外周血单核细胞中齐多夫定、拉米夫定和阿巴卡韦(卡波韦)的细胞内三磷酸代谢物。
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Simultaneous quantification of stavudine, lamivudine and nevirapine by UV spectroscopy, reverse phase HPLC and HPTLC in tablets.采用紫外光谱法、反相高效液相色谱法和高效薄层色谱法同时定量测定片剂中的司他夫定、拉米夫定和奈韦拉平。
J Pharm Biomed Anal. 2005 Sep 15;39(3-4):801-4. doi: 10.1016/j.jpba.2005.04.044.
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Simultaneous determination of the HIV nucleoside analogue reverse transcriptase inhibitors lamivudine, didanosine, stavudine, zidovudine and abacavir in human plasma by reversed phase high performance liquid chromatography.采用反相高效液相色谱法同时测定人血浆中HIV核苷类似物逆转录酶抑制剂拉米夫定、去羟肌苷、司他夫定、齐多夫定和阿巴卡韦。
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