Transfer of TLC screening methods for azithromycin, imipramine HCl, and sulfadoxine + pyrimethamine tablets to quantitative HPTLC-densitometry methods

ABSTRACT

Transfer of three thin-layer chromatography (TLC) mobile kit protocols for detecting fake drugs in pharmaceutical products to quantitative high-performance TLC (HPTLC)–densitometry methods was carried out using a model process published earlier. The developed and validated methods for tablets containing azithromycin, imipramine HCl, and sulfadoxine + pyrimethamine involved EMD Millipore Premium Purity silica gel 60 F₂₅₄ plates, automated sample, and standard solution application with a CAMAG Linomat 4, and automated densitometry with a CAMAG Scanner 3 for detection, identification, and quantification.

KEYWORDS:

• Azithromycin
• imipramine HCl
• model process for TLC to quantitative HPTLC transfer
• pharmaceutical product analysis
• pyrimethamine
• sulfadoxine
• thin-layer chromatography
• TLC

Acknowledgments

The authors thank Thomas Layloff, Senior Quality Assurance Advisor, supply chain management system (SCMS), Arlington, VA, USA, for his support of this research; reviewing the manuscript prior to its submission for publication, and arranging for delivery of analyzed tablets supplied by the Dar es Salaam, Tanzania, Office of SCMS. We also thank EMD Millipore Corp. for providing the premium purity glass HPTLC plates and the aluminum-backed TLC plates used in our experiments. Danhui Zhang and Jacob Strock were supported by the Lafayette College EXCEL Scholar Program.