The Quality of Antimalarials - A Study in Selected African Countries - EDM Research Series No. 030: 2. Methodology: 2.2 Dissolution testing: 2.2.1 Dissolution method for chloroquine tablets

The Quality of Antimalarials - A Study in Selected African Countries - EDM Research Series No. 030
(2003; 67 pages)

Table des matières

Authors
Country Research Team Leaders
Laboratory Support
Acknowledgements
Acronyms
Executive summary
1. Background
2. Methodology
	2.1 Analytical methods
		2.1.1 Method for the assay of chloroquine syrup
		2.1.2 Method for the assay of chloroquine tablets
		2.1.3 Method for the assay of sulphadoxine/pyrimethamine tablets
	2.2 Dissolution testing
		2.2.1 Dissolution method for chloroquine tablets
		2.2.2 Dissolution method for sulphadoxine/pyrimethamine tablets
3. Results
4. Discussion
	4.1 Is there a problem?
	4.2 What is the magnitude of the problem?
	4.3 Is the problem limited to a particular distribution level?
	4.4 Is the problem limited to imported or domestic products?
	4.5 Limitations of the methodology
5. Conclusions and recommendations
	5.1 Conclusions
	5.2 Need for further studies
	5.3 Recommendations for further studies
	5.4 Recommendations for quality and bio-equivalence surveillance
References
Tables
	Table I: Combined country results: percentage failure of samples
	Table II: Combined country results: percentage failure of samples at various collection points
	Table III: Percentage failure of samples as per origin (manufacturer)
	Table IV: Number of samples collected and analysed
	Table IVa: Country results from various collection points - Participating country: Gabon
	Table IVb: Country results from various collection points - Participating country: Ghana
	Table IVc: Country results from various collection points - Participating country: Kenya
	Table IVd: Country results from various collection points - Participating country: Mali
	Table IVe: Country results from various collection points - Participating country: Mozambique
	Table IVf: Country results from various collection points - Participating country: Zimbabwe
	Table IVg: Country results from various collection points - Participating country: Sudan
	Table Va: Country results according to origin of manufacturer - Participating country: Gabon
	Table Vb: Country results according to origin of manufacturer - Participating country: Ghana
	Table Vc: Country results according to origin of manufacturer - Participating country: Kenya
	Table Vd: Country results according to origin of manufacturer - Participating country: Mali
	Table Ve: Country results according to origin of manufacturer - Participating country: Mozambique
	Table Vf: Country results according to origin of manufacturer - Participating country: Zimbabwe
Annexes
	ANNEX: 1A
	ANNEX: 1B
	ANNEX: 1C
	ANNEX: 2A
	ANNEX: 2B
	ANNEX: 2C
	ANNEX: 3A
	ANNEX: 3B
	ANNEX: 3C
	ANNEX: 4A
	ANNEX: 4B
	ANNEX: 4C
	ANNEX: 5A
	ANNEX: 5B
	ANNEX: 5C
	ANNEX: 6A
	ANNEX: 6B
	ANNEX: 6C
	ANNEX: 7A
	ANNEX: 7B
	ANNEX: 7C
Other documents in the EDM Research Series
EDM Research Series No. 30

2.2.1 Dissolution method for chloroquine tablets

The dissolution parameters for chloroquine tablets (USP 24) were as follows:

Apparatus:	Apparatus 2 of the USP
Stir rate:	100 rpm
Dissolution medium:	900 ml water
Q-value:	75%
Time:	45 minutes
Sample volume:	5 ml

Six tablets^a were introduced into the dissolution vessels. Samples (5ml) of the dissolution media in the different vessels were withdrawn after 45 minutes and after further dilution, analysed for chloroquine content according to the prescribed UV spectrophotometric method in the USP for the dissolution testing of chloroquine phosphate tablets. The amount of chloroquine dissolved after 45 minutes is expressed as a percentage of the label claim.

^a Where fewer than six tablets were available, at least three were analysed for dissolution in order to indicate trends