Standardization and comparative analysis of the quality of acetylsalicylic acid tablets

Abstract

Currently, the pharmaceutical industry offers a fairly large number of acetylsalicylic acid (ASA) tablets. Relevant is their high quality, regardless of the manufacturer, the stability of indicators in the process of mass production. Objective: comparative analysis of the main quality indicators of ASA tablets of domestic pharmaceutical manufacturers, improvement of the test «Dissolution». Materials and methods. ASA uncoated tablets, 500 mg, 4 series from two pharmaceutical manufacturers. Evaluation of the quality of tablets and statistical processing of the results of a chemical experiment were carried out according to the relevant methods of the State Pharmacopoeia of the Russian Federation. Results. ASA tablets were standardized according to the following indicators: description, identity, mass uniformity of dosage forms, disintegration, abrasion, quantitative determination of the active substance, dissolution, impurities (salicylic acid). The dissolution profiles of ASA were studied depending on the dissolution medium. Compliance of all samples with the requirements of regulatory documentation was established. A unified test method "Dissolution" for ASA tablets is proposed. Conclusions. The identical composition of the excipients used, the high quality and pharmaceutical equivalence of ASA tablets of different production series and manufacturers have been established.