Biological methods of analysis in quality control of medicines

Abstract

Introduction: In addition to chemical and physicochemical methods in pharmaceutical analysis the biological methods is used as well. Biological evaluation of drugs happens usually by evaluation of both intensity biological effect (pharmacological) and of its toxicity. Biological methods are used, when the conclusion about the purity or toxicity of the pharmaceutical product can’t be made by using physical, chemical or physicochemical methods, or when the method of obtaining of the drug can’t guaranty the stability of its activity (ex: antibiotics ). Biological analysis is the method of identifying drug substances and assay, based on the use of living organisms as analytical indicators. These organisms will populate environments chemically strictly determined. Biological methods of analysis permit determination of specific properties of the medicines. Biological methods consist in the comparing the specific characteristics of the standard and analyte in the determination of the analytical signal and the amount of studied parameter. Animals, such as cats, dogs, birds, toads etc. are used in biological assays. Isolated organs (ex: skin), separated from the cell culture (the constituent elements of the blood), as well as cultures of microorganisms are also used in the quantitative analysis. Substance activity is expressed in units of action. Materials and Methods: Analysis of pharm acopoeia’s monographs of British, European, Romanian, Belorussian and Russian Pharmacopeias. Results: Biological methods exposed in pharmacopoeias are similar to the methodology and recommendations for the analysis of different substances. Quantitative determination obtained by biological method of insulin, antibiotics, heparin and cardiac glycosides is stipulated in all pharmacopoeias. European and Belarus Pharmacopoeias are more focused on the assay of the vaccines and coagulation factors. British Pharmacopoeia proposes quantitative determination of monoclonal antibodies. Conclusion: Biological methods of analysis are recommended for antibiotics, insulin, cardiac glycosides, heparin, blood clotting factors, serums and vaccines. These methods are best suited to obtain adequate information about specific qualities of substances.