ANALYSIS OF APPROACHES TO THE DEVELOPMENT AND VALIDATION OF THE METHODS OF ANALYSIS OF SOME ACTIVE PHARMACEUTICAL INGREDIENTS FROM THE GROUP OF CALCIUM CHANNEL BLOCKERS IN DRUGS AND BIOLOGICAL LIQUIDS
DOI:
https://doi.org/10.22159/ijap.2019v11i3.32498Keywords:
Calcium channel blockers, Amlodipine, Nifedipine, Verapamil, ValidationAbstract
Calcium channel blockers prevent calcium from entering cells of the heart and blood vessel walls, resulting in lower blood pressure. Calcium channel blockers, also called calcium antagonists, relax and widen blood vessels by affecting the muscle cells in the arterial walls. Physico-chemical analysis methods are increasingly being introduced into fundamental pharmaceutical research and pharmaceutical analysis practice, taking into account their high sensitivity, accuracy, specificity and expressiveness.
Analytical method development is increasingly being introduced into fundamental pharmaceutical research and pharmaceutical analysis practice, taking into account their high sensitivity, accuracy, specificity and expressiveness.
Search criteria was analytical method development for medicines from group of calcium channel blockers. Literature survey has been done in range of years 1990-2018 to make the review updated and comprehensive and to show the new approacheches to the development of the methods of analysis of calcium channel blockers. The sources were world recognized journals and key words used as filter were calcium channel blockers, amlodipine, nifedipine, verapamil, validation, method development, spectrophotometry, HPLC, UHPLC. Chromatographic methods of analysis amongst others have the greatest specificity and objectivity and allow for qualitative and quantitative determination of API in combinated dosage forms and biological fluids without prior separation of the components. We can conclude that analysts are constantly working on developing new methods of analysis and their optimization in order to save time and consumables, which also ensures the efficiency of the developed method. The main disadvantage of the described methods of API analysis can be considered long term from the beginning of chromatography to API release and specific solvents used as the mobile phase in HPLC. It is necessary to develop methods and to select such chromatographic conditions that will provide high speed and high efficiency at lower pressure of the system. This reduces the amount of used mobile phase, which reduces cost analysis accordingly, while at the same time providing the necessary specificity, accuracy and reproducibility of the results of the analysis during quality control. Also, the reduction of analysis time is achieved by simplifying the conditions for sample preparation.
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