Etude comparative des profils de dissolution in vitro de quinine sulfate générique et princeps en utilisant la Chromatographie Liquide Haute Performance

Introduction : La quinine est une molécule préconisée pour le traitement du paludisme dans les régions où les souches de P. falciparum sont poly-résistantes. Face à l'importante utilisation de ses médicaments génériques d'une part, et au fléau des médicaments de qualité inférieure d'autre part, il devient plus que nécessaire d'appuyer les données des tests physico-chimiques par celles de dissolution in vitro dont l'évaluation et la comparaison des cinétiques permettra de prédire le comportement in vivo du principe actif et par conséquent l'efficacité du médicament générique. L'objectif de la présente étude était de réaliser une étude comparative de la cinétique de dissolution d'un princeps et d'un générique à base de quinine comprimé 300 mg commercialisés à Kinshasa.Matériels et méthodes : L'étude a été réalisée en utilisant trois milieux de pH différents (1,2 - 4,5 - 6,8) tels que recommandés par l'Agence Européenne de Médicament et en se servant d'un appareil de dissolution, tandis que l'équipement de chromatographie liquide à haute performance couplée à un détecteur à barrette de diodes a été utilisé pour la quantification. La méthode statistique fit factor a été appliquée pour comparer les résultats de dosage de la quinine dans les trois milieux tout en ayant évalué le biais à différents temps de dissolution.Résultats : Les différents échantillons de médicaments générique et princeps ont été conformes quant à l'identification et au dosage de la quinine, par contre leurs cinétiques de dissolution étaient non-similaires.Discussion : Ceci pourrait avoir une influence sur l'efficacité du produit générique et la sécurité des consommateurs, dénotant l'importance d'examiner les profils de dissolution des génériques avant toute autorisation de mise sur le marché plus particulièrement dans les pays en voie de développement

A comparative evaluation of the pharmaceutical quality of different brands of metformin hydrochloride tablets available in Abuja, Nigeria

Background: Metformin hydrochloride tablets are the most commonly prescribed drug for the management of Type II Diabetes Mellitus. This has resulted in increased importation and manufacturing of various brands of the tablets in Nigeria. Objective: To evaluate the pharmaceutical quality of different brands of metformin hydrochloride tablets available in Abuja, Nigeria. Method: Ten brands of metformin hydrochloride tablets were purchased and subjected to pharmaceutical quality evaluations such as friability, hardness, disintegration and dissolution tests. Content of active pharmaceutical ingredient (API) was determined using spectrophotometric analysis as well as reverse phasehigh performance liquid chromatography (RP-HPLC).Results: All the brands were elegantly labelled, packaged and within their shelf lives. With exception of one brand, they all had NAFDAC registration number. The weight uniformity, friability, hardness and disintegration time values for all the brands were within acceptable limits. Three brands of the products released less than 70 % of their API after 45 min and therefore failed the dissolution test. There was disparity between content assay results using UV spectrophotometry and HPLC. HPLC results showed that only brand failed the test by having 86 % of the API while with UV spectrophotometry; four brands failed the test.Conclusion: This investigation suggest that four brands of metformin hydrochloride tablets available in Abuja, did not met official specifications even though only one brand was implicated by HPLC analysis. Consequently, this research would recommend continuous sentinel surveillance of metformin tablets and the use of HPLC for product analysis for its high sensitivity and accuracy

HPLC analysis of nicotinamide, pyridoxine,riboflavin and thiamin in some selected food products in Nigeria

Food fortification is an important tool for improving the health of the population. Motivated by this; the National Agency for Food and Drug Administration and Control (NAFDAC) has in the past few years embarked on a campaign to create this awareness. There has been varying degree of compliance to this; and so it is of utmost importance to know the food products that contribute significantly to the dietary vitamin B intake. This study investigates the amount of four Vitamin B compounds; namely nicotinamide; pyridoxine; riboflavin and thiamin; present in different packaged food items available in Lagos metropolis of Nigeria. The food items analyzed include dairy products; fruit juices and cereal products. These foods were chosen because of their widespread consumption in the area. The analysis was done using a high performance liquid chromatographic technique with a UV detector. The separation was carried out on a C18 column; using a mobile phase made up of 70buffer (a solution of sodium salt of hexane sulphonic acid) and 30HPLC grade methanol. The identification was based on retention time match against a standard while the quantitation was based on the peak area match against those of a standard. The calibration curves for the standards were linear with a linear regression coefficient close to unity