[HPLC used in the validation of simple methods for research of degradation products in essential drug tablets].
HPLC have been used to validate simple methods to be employed in developing countries (DC) for the quality control of drugs. As the important lack of analytical material in DC, colorimetric methods have been used. These are subjected to visual appreciation of the color intensity. Two essential drugs have been selected: aspirin, hydrochlorothiazide. For each compound, standardization of concentration's degradation product by colorimetry and HPLC have been achieved in proximity of the restricted norms of pharmacopoeia. These results have been applied to tablets exposed to stressed conditions (t(0) = 60 and humidity = 75%). The results obtained by colorimetric method were similar to HPLC's ones.
Smahi
Z
Z
Centre Universitaire de Mesure et d'Analyse, Laboratoire de Pharmacotechnie Industrielle, Faculté de Pharmacie, Lille.
Huvenne
J P
JP
Traisnel
M
M
D001241:Aspirin / Q000008:administration & dosage / Q000032:analysis / Q000378:metabolism*; D002851:Chromatography, High Pressure Liquid; D003124:Colorimetry / Q000379:methods*; D003906:Developing Countries; D004335:Drug and Narcotic Control; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000032:analysis / Q000378:metabolism*; D011786:Quality Control; D013607:Tablets
D013607:Tablets; D006852:Hydrochlorothiazide; D001241:Aspirin
Validation par HPLC de méthodes simples pour la recherche de produits de dégradation dans les comprimés de médicaments essentiels.