Development and validation of eco-friendly micellar organic solvent-free HPLC method for the simultaneous determination of some antihypertensive combinations

Bahgat, Eman A.; Saleh, Hanaa; Reda, Alaa; Fawzy, Michael Gamal

doi:10.1016/j.microc.2022.107740

Cited by 9 publications

(5 citation statements)

References 19 publications

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“…Recently, there is a trend toward green chemistry in all methods of analysis, spectrophotometry or chromatography or electrochemistry…et al, for example micellar HPLC method for separation of anti-diabetic drugs [ 22 ], anti-hypertensive drugs [ 23 ] and drugs for treatment of common cold [ 24 ].…”

Section: Resultsmentioning

confidence: 99%

Development of green micellar HPLC–DAD method for simultaneous determination of some sulbactam combinations used in COVID-19 regimen

et al. 2023

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In a new attempt to separate some sulbactam combinations by green chemical method we came up with this research in which an ecofriendly, green, sustainable and selective method was established for separation of four antibiotics, namely, cefoperazone (CFP), cefixime (CFX), ampicillin (AMP) and sulbactam (SLB). No organic solvents were used in the composition of the mobile phase as it was replaced by mixing two surfactants together, sodium dodecyl sulfate (SDS) and polyoxyethylene-23-lauryl ether (Brij-35). Effect of varying the concentrations of the two surfactants on chromatographic separation was studied. Optimum separation was maintained using a mobile phase consisting of 0.01 mol/L SDS, 0.03 mol/L Brij-35, 0.4% Tri-ethylamine (TEA) and pH of 2.8 adjusted by using 1 M ortho-phosphoric acid on reversed phase Isère C18 BDS column with temperature of 40 °C at flow rate 1 mL/min, wavelength 215 nm, and the total run time was 6 min. Validation of the proposed method has been made according International Conference of Harmonization (ICH) guidelines at linearity range of 10–200 µg mL−1 for all drugs under study, high accuracy results (recovery range 98.39–100.35%). and the variation coefficient (RSD) of the points on the calibration curve was ranged from (0.1–1.7%) indicating precise method. The LOQ was (6.09 μg mL−1) for CFP, (6.07 μg mL−1) for CFX, (3.85 μg mL−1) for AMP and (7.20 μg mL−1) for SLB. Successful applications were made on marketed dosage forms with recovery range of (100.16–102.25%) and RSD of (0.03–1.88%). The method was verified on the Green Analytical Procedure Index (GAPI) and Analytical Greenness metric approach (AGREE) and it was found to be an excellent green alternative method.

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Section: Resultsmentioning

confidence: 99%

Development of green micellar HPLC–DAD method for simultaneous determination of some sulbactam combinations used in COVID-19 regimen

et al. 2023

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“…These results showed the green effect of the developed new method on both GAPI and AGREE metrics for CAP analysis. In addition, when the developed RP-HPLC method was compared with the reported methods in the literature, it stands out with its shorter analysis time and is environmentally friendly [17,29,30]. In conclusion, the correct use of drugs in recommended doses has important effects on the quality of the treatment of diseases and on human health.…”

Section: Green Assessment Using Analytical Greenness Calculator (Agre...mentioning

confidence: 96%

Green Procedure Index Assessment of the Novel Stability-Indicating Rp-HPLC Method for the Determination of Captopril From Pharmaceutical Dosage Form

Erkmen

Uslu

2023

Ankara Ecz. Fak. Derg.

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Objective: In this study, it was aimed to develop a novel reverse-phase liquid chromatography method for the ultra-sensitive determination of the antihypertensive drug captopril, using paracetamol, which is the common pain killer, as the internal standard. Optimization of all experimental conditions including composition of mobile phase, flow rate, and column temperature was carried out step by step, and the method validity of the developed method was examined according to international validation guidelines. Calibration range, linearity, the limit of determination, the limit of quantification, robustness, accuracy from commercial tablet samples, and method stability were examined in detail. In addition, the greenness profile for the developed method was assessed with the Green Analytical Procedure Index and Analytical Greenness Calculator techniques, which are frequently used in the literature. Material and Method: The chromatographic method was conducted with an XBridge C18 column (25 cm x 4.6 mm ID; 5 µm) packed with fully porous silica materials. All analyses were performed isocratically with a mobile phase containing acetonitrile:5 mM, pH 7.0 ammonium acetate solution (50:50, v/v) at a flow rate of 1.5 ml min-1. The injection volume was 5 μl, and the column was kept at 25°C in a column oven. The column eluate was monitored at 220 nm. Under optimized conditions, retention times of captopril, and paracetamol were approximately 1.59, and 2.0 min, respectively. Result and Discussion: This study described a fully validated, simple, sensitive, accurate, linear, precise, and reproducible reversed-phase liquid chromatography method for the determination of captopril in tablet samples. Under optimal experimental conditions, the linear range was found in the range of 0.5-200 µg ml-1 and the correlation coefficient was greater than 0.99. Method precision was acceptable, with coefficients of variation between 0.05% and 0.61%. In addition, as a result of the recovery studies carried out on the tablet samples, the accuracy was found to be within satisfactory limits between 99.45% and 102.55%. Moreover, the greenness profile of the developed method also showed that the method is environmentally friendly.

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“…From the literature survey, various approaches have been reported for the estimation of NIF, CAP and BIS alone or in combination with other drugs. The reported methods include HPLC (Ahmed et al, 2018; Andal et al, 2022; Bahgat et al, 2022; Kondratova et al, 2017; Rashid et al, 2022; Rastkari et al, 2013; Sultan et al, 2013; Sultana et al, 2011; Tatar Ulu & Aydoğmuş, 2012), LC–MS/MS (Giebułtowicz et al, 2015; Grigoriev et al, 2016; Logoyda, 2020; Logoyda et al, 2020; Logoyda et al, 2021; Todevska et al, 2022; Tonooka‐Kubota et al, 2022; Tutunji et al, 2009; Zhao et al, 2023), HPTLC (Aayushi & Shah, 2022; Chitlange et al, 2009; Kakde et al, 2008; Shah et al, 2019), spectrofluorimetric (Abd Elhaleem et al, 2022; Abdelwahab et al, 2018; Attia et al, 2023; Derayea et al, 2022; Dewangan et al, 2022; Dong et al, 2022; Han et al, 2022; Khan et al, 2014; Roshdy et al, 2023; Sheng et al, 2022; Wang et al, 2022; Wu et al, 2022; Xi et al, 2022), UV spectrophotometric (Abed, 2020; Gouda & Amin, 2010; Gudruman et al, 2012; Hamad et al, 2023; Mishra, 2022; Tulasamma & Venkateswarlu, 2016; Ulu & Kel, 2012) and electrochemical methods (Al‐Farhan et al, 2023; Frag et al, 2019; Górska et al, 2022; Hassan et al, 2022; Karimi‐Maleh et al, 2017; Khairy et al, 2017; Koçak & İpek, 2022; Mokhtari et al, 2018; Mourad et al, 2020; Pourhakkak et al, 2022; Soomro et al, 2017; Zare et al, …”

Section: Introductionmentioning

confidence: 99%

LC–MS/MS bioanalytical method for the quantitative analysis of nifedipine, bisoprolol, and captopril in human plasma: Application to pharmacokinetic studies

Abdel‐Megied

Kovalenko

Elbarbry

et al. 2023

Biomedical Chromatography

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In this study, the development and validation of an accurate and highly sensitive LC–MS/MS method were performed for the estimation of nifedipine, bisoprolol and captopril in real human plasma. Liquid–liquid extraction using tert‐butyl methyl ether was efficiently applied for extraction of the analytes from plasma samples. The chromatographic separation was carried out using an isocratic elution mode on the X‐terra MS C18 column (4.6 × 50 mm, 3.5 μm). The mobile phase consisted of methanol–0.1% formic acid (95:5, v/v) for determination of nifedipine and bisoprolol and acetonitrile–0.1% formic acid (70:30, v/v) for determination of captopril with a flow rate of 0.5 ml/min. Acceptable results regarding the different validation characteristics of the analytes were obtained in accordance with US Food and Drug Administration recommendations for bioanalytical methods. The developed approach was linear over concentration ranges of 0.5–130.0, 50.0–4,500.0 and 0.3–30.0 ng/ml for nifedipine, captopril and bisoprolol, respectively. The method revealed a sufficient lower limit of quantification in the range of 0.3–50.0 ng/ml, as well as high recovery percentages, indicating high bioanalytical applicability. The proposed method was efficiently applied to a pharmacokinetic evaluation of a fixed‐dose combination of the analytes in healthy male volunteers.

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Development and validation of eco-friendly micellar organic solvent-free HPLC method for the simultaneous determination of some antihypertensive combinations

Cited by 9 publications

References 19 publications

Development of green micellar HPLC–DAD method for simultaneous determination of some sulbactam combinations used in COVID-19 regimen

Development of green micellar HPLC–DAD method for simultaneous determination of some sulbactam combinations used in COVID-19 regimen

Green Procedure Index Assessment of the Novel Stability-Indicating Rp-HPLC Method for the Determination of Captopril From Pharmaceutical Dosage Form

LC–MS/MS bioanalytical method for the quantitative analysis of nifedipine, bisoprolol, and captopril in human plasma: Application to pharmacokinetic studies

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