Solvent‐free mixed micellar mobile phases: An advanced green chemistry approach for reversed‐phase HPLC determination of some antihypertensive drugs

Ibrahim, Adel Ehab; Elmansi, Heba; Belal, Fathalla

doi:10.1002/jssc.202000429

Cited by 25 publications

(11 citation statements)

References 21 publications

(21 reference statements)

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“…Since column is the heart of HPLC where all separations are to be made, reversed phase C18, normal phase silica and bound cyano stationary phases were compared for efficiency in separation. RP-C18 was found the best option since it provided lower organic solvent consumption in better separation efficiency when compared with cyano-bound and normal stationary phase chromatography [ 2 ]. The chosen column's particle size was countered by column backpressure.…”

Section: Resultsmentioning

confidence: 99%

“…It is characterized by the increment of systolic and diastolic blood pressures, one of them or both above normal levels [ 1 ]. In 2015, it was considered as a remarkable risk factor for worldwide morbidity and the growing of mortality rates and causes with highly estimated domination of 10.7 million deaths [ 2 ]. Hence, the use of anti-hypertensive agents has a vital role in control of the resulting elevated blood pressure and its consequent illnesses [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

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Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

et al. 2022

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Angiotensin-converting enzyme inhibitors are one of the most widely used anti-hypertensive drugs which are used to reduce hypertension. In 2018, the United States Food and Drug Administration together with the European Medicine Agency declared the presence of carcinogenic nitrosamine impurities such as nitrosodiethylamine (NDEA) in some of the products, including valsartan (VLS) and losartan (LOS), and drugs' recall procedures were started. Thus, they should be controlled to be below the acceptable cancer risk level to ensure safety of the pharmaceutical products. Therefore, sensitive and reliable analytical methods were required for detection and quantitation of NDEA in bulk and finished drug products. Green analytical chemistry has received great interest to minimize the amount of organic solvents consumed without loss in chromatographic performance. A green and sensitive HPLC method was developed for the determination of NDEA in LOS and VLS using mobile phase of 0.02 M ammonium acetate adjusted to pH 7.2 and ethanol in gradient manner. Limits of detection and limits of quantification for NDEA were estimated to be 0.2 and 0.5 µg ml −1 , respectively. The standardized limits of NDEA impurity in drug substances were set as 0.56 ppm, which indicates the feasibility of its determination by the proposed conventional method without need for expensive instrumentations (e.g. MS/MS detectors) that are not found in most pharmaceutical quality control laboratories.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

et al. 2022

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“…However; attention was then drawn to the impact of analytical chemistry as well to environmental safety. Greening analytical methodologies can contribute significantly to reduce environmental pollution 28 . For instance, a conventional HPLC system in quality control laboratory can generate up to 0.5 L of organic waste daily.…”

Section: Resultsmentioning

confidence: 99%

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Sayed

Ibrahim

Sharaf

2021

Journal of Chemometrics

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The ternary mixture under study is a recent hepatitis‐C antiviral medicine composed of three new directly acting antiviral drugs, namely, ombitasvir, paritaprevir, and ritonavir. They are co‐formulated as a single‐dose combined tablet dosage form. With more than 170 million infected patients worldwide, a large production scales of antivirals medicine is expected, and hence, new simple and fast methodologies are required to cover millions of analyses that are done routinely in the different pharmaceutical quality control and research laboratories. Ultraviolet spectrophotometry represents sensitive, fast, and cheap tool of analysis in all research and quality control laboratories that can cover the massive quality control of these regimens. However, the simultaneous determination of these three drugs using multivariate chemometric methods represents a high challenge as their spectra are strongly overlapping besides the large difference in their potency within the same tablet. In this research paper, four new different multivariate chemometric methods were developed for their simultaneous determination, namely, classical least square (CLS), principal component regression (PCR), partial least squares (PLS), and genetic algorithm‐partial least squares (GA‐PLS) techniques. The validated methods do not require extraction, separation, or derivatization steps. A comparative study was conducted among the four developed methods. All methods provided satisfactory results, whereas GA‐PLS showed better analytical performance as it had the lowest error with good higher correlation coefficient. The methods were applied in the simultaneous determination of the three drugs in pure form and in their combined tablet dosage form. The comparison confirmed agreement of the values obtained for all techniques.

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“…Among the developed techniques, mixed-micellar mobile phases demonstrated adequate performance at replacing hazardous organic solvents [7,8]. The combination of the non-ionic polyoxyethylene surfactant (Brij-35) and the anionic sodium lauryl sulfate (SLS) surfactant improved the elution power in RP stationary phases without the loss of their separation efficiency [9]. This technique involves much lower cost, toxicity and environmental harm; moreover, it offers unique selectivity and power of solubilization.…”

Section: Introductionmentioning

confidence: 99%

Green Stability Indicating Organic Solvent-Free HPLC Determination of Remdesivir in Substances and Pharmaceutical Dosage Forms

et al. 2021

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A green liquid chromatographic method is considered in this work to minimize the environmental impact of waste solvents. One important principle is to replace or eliminate the use of hazardous organic solvents. Organic impurities in any active pharmaceutical ingredient could arise either during the process of its synthesis, or as degradation products developed throughout the shelf-life. Remdesivir (RDS) is an antiviral drug, approved by the US Food and Drug Adminstration (-FDA), to treat SARS-Cov-2 virus during its pandemic crisis. We studied the stability of remdesivir against several degradation pathways using the organic solvent-free liquid chromatographic technique. Separation was performed on RP-C18 stationary phase using mixed-micellar mobile phase composed of a mixture of 0.025 M Brij-35, 0.1 M sodium lauryl sulfate (SLS), and 0.02 M disodium hydrogen phosphate, adjusted to pH 6.0. The mobile phase flow rate was 1 mL min−1, and detection was carried out at a wavelength of 244 nm. We profiled the impurities that originated in mild to drastic degradation conditions. The method was then validated according to International Conference of Harmonization (ICH) guidelines within a linearity range of 5–100 μg mL−1 and applied successfully for the determination of the drug in its marketed dosage form. A brief comparison was established with reported chromatographic methods, including a greenness assessment on two new metrics (GAPI and AGREE). This study is the first to be reported as eco-friendly, solvent-free, and stability indicating LC methodology for RDS determination and impurity profiling.

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Solvent‐free mixed micellar mobile phases: An advanced green chemistry approach for reversed‐phase HPLC determination of some antihypertensive drugs

Cited by 25 publications

References 21 publications

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

Chemometry‐assisted UV‐spectrophotmetric methods for the simultaneous determination of paritaprevir, ritonavir, and ombitasvir in their combined tablet dosage forms: A comparative study

Green Stability Indicating Organic Solvent-Free HPLC Determination of Remdesivir in Substances and Pharmaceutical Dosage Forms

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