JPC - Journal of Planar Chromatography - Modern TLC
Volume/Issue:
Volume 26: Issue 3
Establishment and optimization of an HPTLC method for the analysis of gatifloxacin and related substances by design of experiment
Authors:
Dou-Sheng Zhang National Institutes for Food and Drug Control Beijing 100050 China

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,
Wen Liu National Institutes for Food and Drug Control Beijing 100050 China

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,
Ya-Ping Li National Institutes for Food and Drug Control Beijing 100050 China

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Chang-Qin Hu National Institutes for Food and Drug Control Beijing 100050 China

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Pages:
215–225
Online Publication Date:
05 Jun 2013
Publication Date:
01 Jun 2013
Article Category:
Research Article
DOI:
https://doi.org/10.1556/jpc.26.2013.3.3
Keywords:
Design of experiment; Uniform design; Central composite design; Gatifloxacin and its related substances; HPTLC
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The objective of this study was to establish and optimize high-performance thin-layer chromatography (HPTLC) analysis of gatifloxacin and related substances by the method of design of experiment (DOE). First, preliminary screening of 22 solvents was performed using uniform design (UD) to establish the developing solvent proposed to be optimized. The optimal proportions of components in the developing solvent were established by using central composite design (CCD) to establish and validate HPTLC analysis of gatifloxacin and related substances. Using DOE, it was found that the optimal proportions (by volume) of components in the developing solvent in the HPTLC analytical method were methanol-1,2-dichloroethane-concentrated ammonia solution-acetonitrile (2.8:7.2:0.5:0.5, v/v). Methodological validation showed that the established HPTLC method could separate gatifloxacin and 8 related substances with similar structures effectively. In particular, impurity pairs with the greatest separation difficulty (due to their similar polarities and dipole moments), e.g., impurity #3 (8-fluorogatifloxacin) and impurity #8 (gatifloxacin 2-methylpiperazine), impurity #3, and substance #9 (gatifloxacin), could also be separated effectively. The HPTLC method was simple, accurate, reliable, and suitable for rapid qualitative analysis of gatifloxacin and related substances in routine tests. Additionally, the analytical results presented here may provide useful supplemental information on the current reversed phase high-performance liquid chromatography (RP-HPLC) method, especially in terms of the mechanism of normal-phase separation.

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Cover JPC - Journal of Planar Chromatography - Modern TLC
JPC - Journal of Planar Chromatography - Modern TLC
Print ISSN:
0933-4173
Online ISSN:
1789-0993

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Journal of Planar Chromatography - Modern TLC
Language English
Size A4
Year of
Foundation		 1988
Volumes
per Year		 1
Issues
per Year		 6
Founder Akadémiai Kiadó
Founder's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 0933-4173 (Print)
ISSN 1789-0993 (Online)

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