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  • 1 National Organization for Drug Control and Research (NODCAR) 6-Abu Hazem street, Pyramids Ave. P. O. Box 29 Giza Egypt
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A simple, rapid and precise thin-layer chromatographic (TLC) method for analysis of escitalopram oxalate (ESC-OX) (S-enantiomer) in presence of “in-process impurities” using β-cyclodextrin (β-CD) and urea as two different selectors was developed and validated as per ICH guidelines. Chromatography was performed on silica gel 60 F254 plates with acetonitrile-0.1% acetic acid-methanol-water (5:0.5:3:1 ν/ν) as a mobile phase containing 3 mg β-CD per 100 cm2 of silica-coated plates as a chiral additive. Using urea 3 mg per 100 cm2 of silica-coated plates as a chiral additive also achieves a good enantiomeric separation with acetonitrile-1% acetic acid-ethyl acetate-methanol-water (5:0.5:1:2:1.5 ν/ν) as a mobile phase. Successful resolution was observed for the (S-enantiomer) ESC-OX, escitalopram cyanodiol, the R-enantiomer and escitalopram N-oxide impurities with significant RF values of 0.75 ± 0.02; 0.40 ± 0.02; 0.31 ± 0.02 and 0.23 ± 0.02, respectively. Densitometric measurement of (S-enantiomer) ESC-OX was carried out at 240 nm. The linear regression analysis data for the calibration plots showed a good correlation coefficient(r = 0.9991) at concentration range of 0.25–10 mg per 10 mL with percentage accuracy 99.74 ± 0.42 for ESC-OX. The limits of detection and quantitation were 0.133 and 0.44 mg per 10 mL, respectively. The proposed TLC method was applied to investigate the enantiomeric purity of (S-enantiomer) ESC-OX in drug substance and drug product. Uniformity of dosage units was demonstrated according to USP guidelines.

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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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