The Quality of Antimalarials - A Study in Selected African Countries - EDM Research Series No. 030
(2003; 67 pages) Voir le document au format PDF
Table des matières
Afficher le documentAuthors
Afficher le documentCountry Research Team Leaders
Afficher le documentLaboratory Support
Afficher le documentAcknowledgements
Afficher le documentAcronyms
Afficher le documentExecutive summary
Afficher le document1. Background
Fermer ce répertoire2. Methodology
Fermer ce répertoire2.1 Analytical methods
Afficher le document2.1.1 Method for the assay of chloroquine syrup
Afficher le document2.1.2 Method for the assay of chloroquine tablets
Afficher le document2.1.3 Method for the assay of sulphadoxine/pyrimethamine tablets
Ouvrir ce répertoire et afficher son contenu2.2 Dissolution testing
Afficher le document3. Results
Ouvrir ce répertoire et afficher son contenu4. Discussion
Ouvrir ce répertoire et afficher son contenu5. Conclusions and recommendations
Afficher le documentReferences
Ouvrir ce répertoire et afficher son contenuTables
Ouvrir ce répertoire et afficher son contenuAnnexes
Afficher le documentOther documents in the EDM Research Series
Afficher le documentEDM Research Series No. 30
 

2.1.1 Method for the assay of chloroquine syrup

There is no analytical monograph in the United States Pharmacopeia (USP) or British Pharmacopoeia (BP) for the assay of chloroquine syrup. A high pressure liquid chromatography (HPLC) method was developed and validated in-house for the determination of chloroquine in chloroquine syrup. Validation of the method was carried out according to the validation criteria of the USP and the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation parameters, such as specificity, linearity, accuracy and precision, as well as chromatographic parameters, such as peak symmetry and resolution, were assessed and optimized.

As the laboratory did not know the type of excipients used in the various formulations, the method was only validated for interference from the most generally used preservatives such as the parabens (hydroxy benzoates) and benzoic acid. Evidence of interference from any other preservative not validated for could not be detected during the analysis, and therefore the HPLC method was assumed to be specific for the determination of chloroquine in chloroquine syrup.

The method parameters were as follows:

HPLC column:

C18, 150 x 4.6 mm

Mobile phase:

75% 0.1M KH2PO4: 25% acetonitrile, 200mg heptane sulfonic acid (pH 3.5)

Detection:

UV at 330 nm

Flow rate:

2ml/min

Injection volume:

20 µl

Performance criteria of the method:

Specificity:

Specific for chloroquine in the presence of hydroxy benzoates and benzoic acid

Precision:

%RSD < 2.0

Linearity:

> 0.98.

Symmetry:

<1.5

Although the method was not specifically validated to indicate all five possible decomposition products due to photo degradation, no peaks suggesting the decomposition of the analyte before or during the analyses were observed.

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