JPC - Journal of Planar Chromatography - Modern TLC
Volume/Issue:
Volume 32: Issue 4
Factor Optimization Study to Develop and Validate a Reversed-Phase Thin-Layer Chromatography Method for the Determination of Trimetazidine Dihydrochloride and Its Reported Impurities in Pharmaceuticals
Author: Suzan Mahmoud Soliman 1
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  • 1 National Organization for Drug Control and Research (NOD-CAR), El-Lagousa 51 Wezaret El-Ziraa St, P.O. Box 12553, Post Code 35521, Giza, Egypt
DOI:
https://doi.org/10.1556/1006.2019.32.4.2
Page Count:
273–283
Publication Date:
01 Aug 2019
Online Publication Date:
Aug 2019
Article Category:
Research Article
Restricted access
Summary A validated reversed-phase thin-layer chromatography (RP-TLC)–densitometry method was developed and optimized for the determination of trimetazidine dihydrochloride (TMZ) and its potential impurities listed in the British Pharmacopoeia, namely, piperazinecarboxaldehyde (Y-145), trimethoxybenzyl alcohol (Y-235), and trimethoxybenzaldehyde (Y-234). Chromatographic separation was performed on aluminum plates pre-coated with silica gel 60 RP-18F using a mixture of acetonitrile–methanol–0.1% aqueous ortho-phosphoric acid pH 6.2 (4.5:4.5:1, V/V) as the developing system. Different factors affecting resolution were studied and optimized. Successful resolution was observed with significant difference in the RF values of 0.21 ± 0.02, 0.35 ± 0.02, 0.5 ± 0.02, and 0.85± 0.02 for TMZ and its impurities, respectively. Densitometric measurement was done at 215 nm over the range of 0.05–10, 0.05–1.1, 0.05–1.2, and 0.04–1.0 µg per spot with lower limits of detection (LOD) and quantification (LOQ) of 20 and 50 ng per spot for TMZ, Y-145, and Y-235, respectively, and 15 and 40 ng per spot for Y-234 impurity. Good accuracy was obtained with mean percentage recoveries of 99.55 ± 1.06, 100.50 ± 1.16, 100.07 ± 1.24, and 99.41 ± 1.11 for TMZ and its impurities, respectively. The developed method was used to investigate the impurity profile of TMZ in drug substance and different products and it was validated as per the International Conference on Harmonisation (ICH) guidelines.
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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
Keywords:
Trimetazidine dihydrochloride; Potential impurities; Stability-indicating reversed-phase thin-layer chromatography; Pharmaceutical products

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