Thin-layer chromatography in testing the purity of pharmaceuticals

Ferenczi-Fodor, K.; Végh, Zoltán; Renger, Bernd

doi:10.1016/j.trac.2006.06.003

Cited by 47 publications

(28 citation statements)

References 38 publications

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“…The technique is simple, cost-effective, versatile, and usable in all laboratories worldwide. It can be easily adapted to any given situation of qualitative or quantitative separation (Ferenczi-Fodor et al, 2006). The uses of TLC in quality control of plant materials include fingerprint profiling for the assessment of chemical constituents of an extract, and quantitative analysis of markers in plant drugs (Mohammad et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

Quality control and TLC profile data on selected plant species commonly found in the Brazilian market

Braz¹,

Wolf²,

Lopes³

et al. 2012

Rev. bras. farmacogn.

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Abstract:The use of thin-layer chromatography (TLC) is a commonplace practice and can be of signifi cant help to different laboratories with quality control, especially those that work with plant extracts and phytotherapeutics. This study evaluated ten species of plants (Schinus terebinthifolius, Arctium lappa, Trichilia catigua, Camellia sinensis, Mikania glomerata, Croton moritibensis, Achyrocline satureioides, Heteropterys aphrodisiaca, Plantago major, Arctostaphylos uva-ursi) that are commonly sold by compounding pharmacies, using TLC with reference substances and pharmacopoeic physical and chemical tests (loss on drying, level of extractives, and total ash content). The results showed that the ten species showed losses on drying consonant with the literature. The level of extractives for two species and total ash for fi ve species were also consonant with the literature, and those of the other species were established in this study. The semipurifi ed extracts of the ten species were assayed by TLC, and the analysis with the use of reference substances proved to be effective, in addition to being practical, simple, versatile, and economically viable.

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Section: Introductionmentioning

confidence: 99%

Quality control and TLC profile data on selected plant species commonly found in the Brazilian market

Braz¹,

Wolf²,

Lopes³

et al. 2012

Rev. bras. farmacogn.

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show abstract

“…One of the major applications of quantitative TLC is the drug quality assessment [1][2][3][4]. The current ICH guidelines [5] require evaluation of specificity of the chromatographic method, as an obligatory part of method validation.…”

Section: Introductionmentioning

confidence: 99%

“…As above, but presenting also an overlayed graph [14] 3. As above, but with correlation values presented [15][16] Review papers by Ferenczi-Fodor [1][2][3][4]6] recommend that the selectivity (in the meaning of "spot purity") must be carefully checked in context of newest TLC state-of-art. Simple overlapping of the spectra should be considered as a subjective approach; correlations as objective measures should be presented as an addition.…”

Section: Introductionmentioning

confidence: 99%

Validation of specificity in quantitative thin layer chromatography—is spectral correlation a reliable measure of spot purity?

Kobyłka

Komsta

2012

Acta Chromatographica

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Summary.The current guidelines of quantitative method development establish a requirement to validate a set of method parameters and the selectivity is one of the most important parameters to be proven. Currently, one of the most frequently used approaches is to measure the spectrum of a spot together with some reference spots and to correlate them. Additionally, several places of the spot (start, middle, end) can be measured and also correlated. In the current paper we perform a simulation done on 170 real spectra with different levels of contamination and noise, establishing the distribution of correlation coefficient. It can be concluded that contamination up to 10% almost cannot be detected by simple correlation measurement, regardless of the noise level. Moreover, at a high noise level there is a very low margin between correlation of different compounds and the correlation of the same (but noisy) spectra. These observations suggest that the spectral correlation cannot be a reliable measure of method specificity and some another chemometric methods need to be searched in further research.

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“…Most organic impurities in drugs are profiled by chromatographic methods of which reversed-phase HPLC [1][2][3][4][5] and thin layer chromatography (TLC) [6] coupled with UV or fluorescent detection have been the most popular for well over a decade. Other approaches reported for impurity profiling involve HPLC-mass spectrometry (MS), gas chromatography (GC) combined with flame ionization [7] or MS [8] detection, as well as some non-chromatographic strategies such as atomic absorption spectrometry [9], fluorimetry [10], UV [11], polarography [12] and nuclear magnetic resonance spectroscopy [13].…”

Section: Introductionmentioning

confidence: 99%

Capillary electrophoresis–electrochemiluminescent detection of N,N-dimethyl ethanolamine and its application in impurity profiling and stability investigation of meclophenoxate

Fu¹,

Wang²,

Wang³

2009

Analytica Chimica Acta

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Thin-layer chromatography in testing the purity of pharmaceuticals

Cited by 47 publications

References 38 publications

Quality control and TLC profile data on selected plant species commonly found in the Brazilian market

Quality control and TLC profile data on selected plant species commonly found in the Brazilian market

Validation of specificity in quantitative thin layer chromatography—is spectral correlation a reliable measure of spot purity?

Capillary electrophoresis–electrochemiluminescent detection of N,N-dimethyl ethanolamine and its application in impurity profiling and stability investigation of meclophenoxate

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