High-performance thin layer chromatography to assess pharmaceutical product quality.

Autor: Kaale E; Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania., Manyanga V; Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania., Makori N; Supply Chain Management System, Dar es Salaam, Tanzania., Jenkins D; FHI360, Durham, NC, USA., Michael Hope S; United States Agency for International Development, Washington, DC, USA., Layloff T; Supply Chain Management System, Arlington, VA, USA.
Jazyk: angličtina
Zdroj: Tropical medicine & international health : TM & IH [Trop Med Int Health] 2014 Jun; Vol. 19 (6), pp. 747-751. Date of Electronic Publication: 2014 Mar 24.
DOI: 10.1111/tmi.12303
Abstrakt: 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.)
Databáze: MEDLINE
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