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HPLC Tests in Quality Control under the Market Surveillance Program for Medicinal Products Containing Amlodipine and Valsartan

Author(s):

Dessislava Ilieva-Tonova*, Ivanka Pencheva and Assena Serbezova  

Abstract:


Background: Quality is one of the three main characteristics of medicinal products. The quality assurance process is multi-stage: during the manufacturing, quality control is the commitment of the manufacturer, but after medicinal products become part of the distribution and pharmacy network, analytical quality control is carried out within the program for Market Surveillance. There are different approaches in conducting quality control of medicinal products under the Market Surveillance Program.

Aim: The aim of the study is to compare the results obtained under two approaches: individual testing and testing by groups with the same active substance.

Methods: In this study, comparative tests for assay and purity were carried out within two groups of medicinal products from the antihypertensive group containing Amlodipine besilate and Valsartan. Analyses were performed in accordance with the available pharmacopoeial monographs, as well as those from literature sources.

Results: The results from the assay tests show a significant difference in the same product tested. Analytical methods for the determination of impurities also show different results when analyzing the same medicinal product.

Conclusion: Considering the performed analytical tests, the obtained results can be used to make several conclusions and suggestions concerning the optimisation of the Annual Market Surveillance Program

Keywords:

Quality control, market surveillance program, amlodipine, valsartan, assay, purity

Affiliation:

Bulgarian Drug Agency, Str. Damyan Gruev 8, Sofia 1303, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Medical University-Sofia, Str. Dunav 2, Sofia 1000, Department of Health Policy and Management, Faculty of Public Health, Medical University-Sofia, Str. „White sea“ 8, Sofia



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