Quality Control of Paracetamol Generic Tablets Marketed in Benin and Search of Its Two Impurities P-Aminophenol and P-Nitrophenol by HPLC-UV/Visible

作     者：Yemoa Loconon Achille Agbokponto Janvier Engelbert Assanhou Assogba Gabin Adetona Pauline Doffon Parfait Ganfon Habib Roland Marini Djang’eing’a Yemoa Loconon Achille;Agbokponto Janvier Engelbert;Assanhou Assogba Gabin;Adetona Pauline;Doffon Parfait;Ganfon Habib;Roland Marini Djang’eing’a

作者机构：Laboratoire de Chimie analytique et Analyse des Médicaments Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé. Université d’Abomey Calavi Cotonou Bénin Laboratoire de Pharmacie Galénique et de Technologie Pharmaceutique Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin Laboratoire de Pharmacognosie et de de Phytothérapie Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin Laboratoire de Chimie Analytique Pharmaceutique Departement de Pharmacie Université de Liège (ULiège) Liège Belgium 

出 版 物：《American Journal of Analytical Chemistry》 (美国分析化学（英文）)

年 卷 期：2022年第13卷第11期

页      面：449-460页

学科分类：08[工学] 0812[工学-计算机科学与技术（可授工学、理学学位）] 

主　　题：Quality Control Substandard Medicines Paracetamol P-Aminophenol P-Nitrophenol Benin 

摘      要：In this work, we evaluated the quality of paracetamol generic tablets while seeking its two main impurities namely 4-para-aminophenol (4-AP) and 4-para-nitrophenol (4-NP) which have nephrotoxic and teratogenic properties. Ninety-four (94) samples were collected at various levels of the medicine supply chain and illegal markets in Benin for quality control tests such as visual inspection, pharmacotechnical tests as mass variation, disintegration test, dissolution test, followed by HPLC UV-Vis identification and assay of paracetamol, 4-AP and 4-NP. The analytes were separated on C18 Lichrocart column (250 mm × 4.0 mm i.d, 5 μm);the mobile phase was MeOH:10 mM ammonium acetate buffer pH 6.8 (35:65) pumped at a flow rate of 1 ml/min. The detection was done at 245 nm. Analysis of our results shows that 77.7% of the samples did not comply with the visual inspection test requirements, 2.1% did not pass the mass variation test, 24.3% of the sample batches didn’t comply with the disintegration test requirements. In addition none of these uncomply batches passed the dissolution test, even if the identification test indicated that all samples contained paracetamol. None contained 4-NP (acceptance limit 0.05% m/m;BP), while 3 of 94 samples contained 4-AP but within acceptance limit (4-AP 0.1% m/m;BP). As for the paracetamol assay, 80.9% complied with the specifications of the pharmacopoeias taken as reference (90% - 110%;USP). Further, broader studies should be conducted according to the same rules of good practice for a more comprehensive analysis of the situation. Generally the quality control of paracetamol in most African countries, particularly in Benin, is based on pharmacotechnical tests and paracetamol assay. This work, in addition to the usual tests, showed the importance to search for paracetamol and other drugs’ impurities during their routine quality control.