Eliangiringa Kaale1, Vicky Manyanga1, Narsis Makori2, David Jenkins3, Samuel Michael Hope4, Thomas Layloff5. 1. Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. 2. Supply Chain Management System, Dar es Salaam, Tanzania. 3. FHI360, Durham, NC, USA. 4. United States Agency for International Development, Washington, DC, USA. 5. Supply Chain Management System, Arlington, VA, USA.
Abstract
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.
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.
Keywords:
zzm321990CCMHPzzm321990; zzm321990HPLCzzm321990; zzm321990HPTLCzzm321990; Comparación en la Calidad de Tecnologías del Medicamento; comparaisons des technologies sur la qualité des Médicaments; drug quality technology comparisons
Authors: Veronika J Wirtz; Hans V Hogerzeil; Andrew L Gray; Maryam Bigdeli; Cornelis P de Joncheere; Margaret A Ewen; Martha Gyansa-Lutterodt; Sun Jing; Vera L Luiza; Regina M Mbindyo; Helene Möller; Corrina Moucheraud; Bernard Pécoul; Lembit Rägo; Arash Rashidian; Dennis Ross-Degnan; Peter N Stephens; Yot Teerawattananon; Ellen F M 't Hoen; Anita K Wagner; Prashant Yadav; Michael R Reich Journal: Lancet Date: 2016-11-08 Impact factor: 79.321