ANALYSIS OF APPROACHES TO THE DEVELOPMENT AND VALIDATION OF THE METHODS OF ANALYSIS OF MELDONIUM IN DRUGS AND BIOLOGICAL LIQUIDS
Introduction. Analytical methods development and validation play important roles in the discovery, development and manufacture of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed. Search criteria was method development of meldonium. Literature survey has been done in range of years 1990–2019 to make the review updated and comprehensive and to show the new approaches to the development of the methods of analysis of meldonium. The sources were world recognized journals and key words used as filter were meldonium, spectrophotometric method, high-performance liquid chromatography, quantitative analysis, method development, validation.
The aim of the study – to analyze the approaches of the development and validation of the methods of analysis of meldonium in drugs and biological liquids.
Conclusion. In light of the benefits discussed in this review, we can conclude that analysts are constantly working on developing new methods of analysis of meldonium in drugs and biological liquids and on their optimization in order to save time and consumables, which also ensures the efficiency of the developed methodology. Literature survey revealed that a number of methods have been reported for estimation of meldonium individually. However, there is no analytical methods reported for the simultaneous analysis of these drugs in a combined dosage formulation.
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