Comparative quality control study of widely used brands of paracetamol tablets in Iraq

Abstract

Based on the World Health Organization definitions, the term quality control refers to the sum of all steps and procedures undertaken by a drug manufacturer to ensure the identity, safety, efficacy and purity of a particular pharmaceutical product. Quality control is an essential operation within the field of pharmaceutical industry and it is a vital part of current Good Manufacture Practice. It ensures that the pharmacokinetic and the pharmacodynamics properties are predictable and reproducible for the same active pharmaceutical ingredient when manufactured by different companies. The quality assurance of oral solid dosage form especially tablets is a priority for drug manufacturing companies. In addition to the apparent features of tablets, tablets must meet other physical specifications and quality standards. These include criteria for weight, weight variation, thickness, hardness, disintegration, and dissolution. In addition the content uniformity was investigated by HPLC technique. Thus, in this project, paracetamol tablets from five different companies which are widely used by Iraqi population were subjected to different quality control tests to indicate whether these products are fit to the standard criteria of the United States Pharmacopeia or not. The data indicated that all tested brands succeeded to pass most tests and failed in others.