High-performance thin layer chromatography to assess pharmaceutical product quality
Tropical Medicine and International Health
Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania; Supply Chain Management System, Dar es Salaam, Tanzania; FHI360, Durham, NC, United States; United States Agency for International Development, Washington, DC, United States; Supply Chain Management System, Arlington, VA, United States
Objective: To assess the sustainability, robustness and economic advantages of high-performance thin layer chromatography (HPTLC) for quality control of pharmaceutical products. Method: We compared three laboratories where three lots of cotrimoxazole tablets were assessed using different techniques for quantifying the active ingredient. Result: The average assay relative standard deviation for the three lots was 1.2 with a range of 0.65-2.0. Conclusion: High-performance thin layer chromatography assessments are yielding valid results suitable for assessing product quality. The local pharmaceutical manufacturer had evolved the capacity to produce very high quality products. © 2014 John Wiley & Sons Ltd.
cotrimoxazole; article; developing country; drug control; drug dosage form; drug quality; high performance thin layer chromatography; Kenya; optical resolution; pilot study; quality control; Tanzania