A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

Nigović, Biljana; Mornar, Ana; Sertić, Miranda

doi:10.5772/48694

Cited by 6 publications

(5 citation statements)

References 117 publications

(197 reference statements)

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“…Previous reports [ 7 , 8 , 9 , 10 , 11 , 12 ] and the spectra, generated in our laboratory, confirmed that statins involved in this study have native fluorescence ( Figure 1 ). This native fluorescence of statins is expected because their chemical structures contain fluorophoric moieties such as extended conjugations and rigid fused aromatic rings with fluorescence-promoting substituents [ 25 ].…”

Section: Resultssupporting

confidence: 87%

“…For quality control of statins, a proper analytical technique is required. The existing techniques for the determination of stains in their pharmaceutical dosage forms are mostly liquid chromatography, electrochemical techniques and spectrometry; these techniques have been reviewed in many reports [ 7 , 8 , 9 , 10 , 11 , 12 , 13 ]. In the pharmaceutical industry, spectrofluorimetric assays are the most convenient and widely used.…”

Section: Introductionmentioning

confidence: 99%

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One-Step Microwell Plate-Based Spectrofluorimetric Assay for Direct Determination of Statins in Bulk Forms and Pharmaceutical Formulations: A Green Eco-Friendly and High-Throughput Analytical Approach

Darwish

Alzoman

et al. 2023

Molecules

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This study describes the development of a one-step microwell spectrofluorimetric assay (MW-SFA) with high sensitivity and throughput for the determination of four statins in their pharmaceutical and formulations (tablets). These statins were pitavastatin (PIT), fluvastatin (FLU), rosuvastatin (ROS) and atorvastatin (ATO). The MW-SFA involves the measurement of the native fluorescence of the statin aqueous solutions. The assay was conducted in white opaque 96-microwell plates, and the fluorescence intensities of the solutions were measured by using a fluorescence microplate reader. The optimum conditions of the assay were established; under which, linear relationships with good correlation coefficients (0.9991–0.9996) were found between the fluorescence intensity and the concentration of the statin drug in a range of 0.2–200 µg mL–1 with limits of detection in a range of 0.1–4.1 µg mL–1. The proposed MW-SFA showed high precision, as the values of the relative standard deviations did not exceed 2.5%. The accuracy of the assay was proven by recovery studies, as the recovery values were 99.5–101.4% (±1.4–2.1%). The assay was applied to the determination of the investigated statins in their tablets. The results were statistically compared with those obtained by a reference method and the results proved to have comparable accuracy and precision of both methods, as evidenced by the t- and F-tests, respectively. The green and eco-friendly feature of the proposed assay was assessed by four different metric tools, and all the results proved that the assay meets the requirements of green and eco-friendly analytical approaches. In addition, ever-increasing miniaturization as handling of large numbers of micro-volume samples simultaneously in the proposed assay gave it a high-throughput feature. Therefore, the assay is a valuable tool for the rapid routine application in the pharmaceutical quality control units for the determination of statins.

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Section: Resultssupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

One-Step Microwell Plate-Based Spectrofluorimetric Assay for Direct Determination of Statins in Bulk Forms and Pharmaceutical Formulations: A Green Eco-Friendly and High-Throughput Analytical Approach

Darwish

Alzoman

et al. 2023

Molecules

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“…The UV absorption spectra of ASP, CLP, and ATV in mixture (1) and ASP, CLP, and ROS in mixture (2) in distilled water at their nominal concentrations ratio in tablets and capsules show strong overlap (Figures 2 and 3). Therefore, it is not possible to directly and simultaneously determine the cited medicines in the two mixes using spectrophotometry 22 . Therefore, the primary goal of this work was to design and validate simple, accurate, and selective spectrophotometric methods that could simultaneously quantify the three medicines present in both combinations using various chemometric approaches and artificial neural networks (ANN).…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, it is not possible to directly and simultaneously determine the cited medicines in the two mixes using spectrophotometry. 22 Therefore, the primary goal of this work was to design and validate simple, accurate, and selective spectrophotometric methods that could simultaneously quantify the three medicines present in both combinations using various chemometric approaches and artificial neural networks (ANN). All of the instrumentations' analytical data is analyzed using multivariate calibrations, including classical least-squares (CLS), principal component regression (PCR), and partial least-squares (PLS).…”

Section: Introductionmentioning

confidence: 99%

A novel eco‐friendly methods for simultaneous determination of aspirin, clopidogrel, and atorvastatin or rosuvastatin in their fixed‐dose combination using chemometric techniques and artificial neural networks

AlSawy¹,

Elkady

Mostafa

2023

Journal of Chemometrics

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In this study, the simultaneous determination of aspirin, clopidogrel, and either atorvastatin or rosuvastatin in their fixed‐dose combination (FDC) formulations has been reported. As a straightforward substitute for employing distinct models for each component, UV spectrophotometry was applied with chemometric approaches and artificial neural networks to achieve this. Three chemometric techniques, including principal component regression (PCR), partial least‐squares (PLS), and classical least‐squares (CLS), were applied in addition to the radial basis function‐artificial neural network (RBF‐ANN). The validation of a set of laboratory‐prepared combinations of aspirin, clopidogrel, and atorvastatin in one ternary mixture and aspirin, clopidogrel, and rosuvastatin in a second ternary mixture was assessed, and the results from the use of these approaches were recorded and compared. The absorbance data matrix matching the concentration data matrix in CLS, PCR, and PLS was created using measurements of absorbances in the range of 250–280 nm at intervals of 0.2 nm in their zero‐order spectra. Then, in order to forecast the unknown concentrations, calibration or regression was created utilizing the concentration and absorbance data matrices. Using RBF‐ANN for the simultaneous determination of aspirin, clopidogrel, and atorvastatin or rosuvastatin in their formulations was achieved by providing the input layer with 151 neurons; there are 2 hidden layers and 3 output neurons were obtained. The green profile of the developed methods has been assessed and compared with previously reported spectrophotometric methods. The suggested techniques were effectively applied to FDC dosage forms that contained the cited medications.

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“…The unknown impurity was isolated by preparative HPLC and characterized by LCMS and NMR techniques. Literature survey shows an analytical method for related impurities by HPLC for Atorvastatin [14][15][16][17][18] , Ezetimibe [19][20][21] and for combination product of Atorvastatin and Ezetimibe is available to determine related impurities of Atorvastatin and Ezetimibe. The presence study is important for identify potential degradation impurity in current marketed product and can control this impurity in formulation as a good product life cycle approach.…”

Section: Introductionmentioning

confidence: 99%

Isolation, Identification and Characterization of Degradation Impurity of Atorvastatin in Fixed Dose Combination of Atorvastatin and Ezetimibe

Desai

Koradia²

2019

Int. J. Pharm. Sci. Drug Res.

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The objective of this study is to isolation and characterization of unknown degradation product of Atorvastatin calcium in combination formulation product with Ezetimibe by using modern techniques of separation and aracterization. An unknown impurity is generating during a forced degradation study of Atorvastatin and Ezetimibe fixed-dose combination tablets. By using the gradient reversed-phase high-pressure liquid chromatographic method, unknown degradation impurity was detected and quantified in the range of 0.05% to 0.2% of Atorvastatin. The impurity was enriched by extreme oxidation degradation of Atorvastatin and isolated through preparative HPLC. The structure of the impurity was characterized by mass and NMR spectrum.

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A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

Cited by 6 publications

References 117 publications

One-Step Microwell Plate-Based Spectrofluorimetric Assay for Direct Determination of Statins in Bulk Forms and Pharmaceutical Formulations: A Green Eco-Friendly and High-Throughput Analytical Approach

One-Step Microwell Plate-Based Spectrofluorimetric Assay for Direct Determination of Statins in Bulk Forms and Pharmaceutical Formulations: A Green Eco-Friendly and High-Throughput Analytical Approach

A novel eco‐friendly methods for simultaneous determination of aspirin, clopidogrel, and atorvastatin or rosuvastatin in their fixed‐dose combination using chemometric techniques and artificial neural networks

Isolation, Identification and Characterization of Degradation Impurity of Atorvastatin in Fixed Dose Combination of Atorvastatin and Ezetimibe

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