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Spectrophotometric, chromatographic and bioanalysis of selected recently approved drugs from 2015–2020 to treat cardiovascular diseases: an analytical review
Bulletin of the National Research Centre volume 47, Article number: 24 (2023)
Heart Study has been operating for more than 40 years, and throughout that time it has found a number of risk variables that interact negatively to have an overall negative effect on cardiovascular disease (CVD) with an estimated 17.9 million deaths per year, CVD is the world's leading cause of death.
In the current study, we present spectrophotometric, chromatographic analysis and bioanalysis methods for qualitative and quantitative evaluation of 15 drugs, including small and large molecules, that the U.S. FDA approved between 2015 and June 2020 to treat CVD’s and in the current review work, they were presented.
The review's conclusion is that spectroscopic, chromatographic and bioanalysis methods play important role in quality control and standardization of recently approved drugs from 2015 to 2020 for treating CVD’s in its bulk, pharmaceutical dosage form, synthetic mixture or human/rat plasma.
Heart Study has been operating for more than 40 years, and throughout that time it has found a number of risk variables that interact negatively to have an overall negative effect on cardiovascular disease (CVD) (Nabel 2003). Experience has revealed that the best method for preventing coronary heart disease is probably a multifactorial one, one that considers all the risk factors (CHD) (Anderson et al. 1991). According to estimates, 17.9 million annual deaths from CVD each year. The collection of heart and blood vessel disorders known as CVDs includes conditions like coronary heart disease, cerebrovascular disease, rheumatic heart disease, and other illnesses. More than four out of every five CVD deaths result from heart attacks and strokes, and one-third of these deaths occur before the age of 70 (WHO report n.d.).
Premature deaths were significantly more common than premature CVD deaths globally (34%) and in Asia (35%) as well as in Europe (22%) and the USA (23%). Ischemic heart disease (IHD) (47%) and stroke (87%) accounted for the majority of CVD deaths (40%). The number of CVD deaths in Asia increased from 5.6 million to 10.8 million during 1990 and 2019, and the proportion of CVD deaths in all deaths increased from 23 to 35%. Furthermore, crude CVD mortality rates increased steadily for both men and women during 1990 and 2019 (Burden and of Disease Collaborative Network. Global Burden of Disease 2019; Zhao 2021).
Drug discovery is a multidisciplinary method that is complex and it still presents a wide range of difficulties for the pharmaceutical industry and related sectors (Drews 2000). There were mainly 201 novel molecules authorized for the treatment of CVDs between 1937 and 2013. (Patridge et al. 2016) The US FDA's Centre for Drug Evaluation and Research (CDER) has approved 15 therapeutic medicines for cardiovascular diseases over the past five years, nine of which are small molecules, with the initial three are macromolecules (Table 1 and Fig. 1). The following is a description of the medications approved under this category (Bhutani et al. 2021).
The major goal of developing and validating analytical methods is to demonstrate that they are accurate, specific, precise, and robust for the particular drug (Doltade and Saudagar 2019; Kagawad et al. 2021).
Literature survey reveals that various analytical method have been developed to estimate recently approved drugs from 2015 to 2020 for treating cardiovascular diseases in bulk, tablet dosage form, synthetic mixture and in biological sample. The method consists of UV Spectrophotometric Analysis, Stability indicating RP-HPLC Method, LC/MS/MS, HPTLC, Spectrofluorimetry. Numerous researchers have worked on various spectrophotometric, chromatographic, and bioanalytical analyses, and they have published their findings in a number of journals and scientific databases. A survey of the literature indicated that, as of this writing, no reports on its detailed review about spectrophotometric and chromatographic analysis and bioanalysis of selected recently approved drugs from 2015 to 2020 for treating cardiovascular diseases. Hence, we attempted to complete the current review work since there is a clear need for collective information regarding spectrophotometric, chromatographic, and bioanalytical analysis that will be useful to other researchers and readers. The need to examine and compare the available analytical and bioanalytical tests used to determine these drugs, either alone or in combination, is essential.
UV Spectroscopy (Verma and Mishra 2018)
Ultraviolet (UV) spectroscopy is an optical spectroscopy technique based on the Beer–Lambert equation, the concentration of the absorbing species in a solution and the path length directly affect the solution's absorbance. It makes use of near-infrared, ultraviolet, and visible light. As a result, it can be used to measure the concentration of the absorber in a solution for a particular path length. Since UV–VIS spectroscopy has been in widespread use for the past 37 years, it has evolved into the most important analytical tool in the modern laboratory. It is important to understand how quickly the absorbance varies with concentration. Other methods could be used in many applications, but none compared to UV–VIS spectroscopy's ease of use, flexibility, precision, speed, and cost-effectiveness. (Table 2).
HPLC methods (LC, RP-HPLC, UPLC) (Saibaba et al. 2016a)
In the pharmaceutical sector, reversed-phase liquid chromatography is the analytical technique that is most frequently utilized liquid chromatographic techniques are used to assess the quality of the drug substance (active pharmaceutical ingredient) and drug product during the drug development process (Table 3).
TLC and HPTLC method (Fenimore and Davis 1981 Feb 1)
Enhanced and improved separation effectiveness and detection limit than thin-layer chromatography (TLC), high-performance thin-layer chromatography (HPTLC) is a sophisticated and automated version of TLC. It is also referred to as flatbed chromatography, planar chromatography, and high-pressure thin-layer chromatography. It is a potent analytical technique that works for both qualitative and quantitative tasks. Depending on the type of solvent solution and adsorbent employed on development plates, separation may be caused through partition, absorption, or both. (Table 4).
LC-MS/MS, LC- MS method (Saibaba et al. 2016b)
Liquid chromatography/Mass Spectrometry (LC/MS) is quickly replacing traditional liquid chromatography as the main method of analysis. It is a powerful analytical technique that combines the liquid chromatography resolving strength and the mass spectrometric detection specificity. Liquid chromatography (LC) is used to separate the components of the sample, and the mass spectrometer is then used to analyze the separated components (MS). The molecular weight, structure, identity, and quantity of particular sample components can be determined using the LC/MS data; charged ions are produced and found by the MS. (Table 5).
Since drug design, bioavailability and safety studies have been greatly influenced by the improvement in quality of life, extremely sensitive and precise analytical techniques are required to meet these objectives. The presented work is focused on the use of various analytical methods such as HPLC (High-Performance Liquid Chromatography), HPTLC (High-Performance Thin-Layer Chromatography), TLC (Thin-Layer Chromatography), UPLC (Ultra Performance Liquid Chromatography), and LC/MS/MS. For the purpose of determining the effectiveness of a medicinal compound in a certain matrix, a critical analytical method should be established for recently approved drugs from 2015 to 2020 for treating cardiovascular disease drug analytes in formulation as well as in API. Various analytical methods detection is appropriate for the examination of recently approved medications from 2015 to 2020 for treating cardiovascular illnesses since it yields precise results at a lower cost than more sophisticated detection methods. This paper provides a summary of the most advanced analytical techniques to estimate the recently approved cardiovascular medications. Analytical chemists would benefit from knowing the essential solvents and their combinations for the tools they have access in the laboratories.
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High-performance liquid chromatography
High-performance thin-layer chromatography
Ultra high-performance liquid chromatography
Liquid chromatography/Mass Spectrometry
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The authors are very thankful to Principal Dr. S. S. Jalalpure and Vice Principal Dr. M. B. Patil for their support and guidance. Authors are also thankful to the department of pharmaceutical Chemistry.
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Gharge, S., Koli, R., Gudasi, S. et al. Spectrophotometric, chromatographic and bioanalysis of selected recently approved drugs from 2015–2020 to treat cardiovascular diseases: an analytical review. Bull Natl Res Cent 47, 24 (2023). https://doi.org/10.1186/s42269-023-01000-5
- Cardiovascular disease
- Pharmaceutical dosage form
- U.S. FDA