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Cost-effective, Sensitive, and Green HPLC Determination of Losartan, Valsartan and their Nitrosodiethylamine Impurity; Application to Pharmaceutical Dosage-forms
Faculty
Pharmacy
Year:
2022
Type of Publication:
ZU Hosted
Pages:
1-10
Authors:
Magda Mohamed Elsayed Elhenawy
Staff Zu Site
Abstract In Staff Site
Journal:
Royal Society open Science Royal society of chemistry
Volume:
Keywords :
Cost-effective, Sensitive, , Green HPLC Determination , Losartan,
Abstract:
Angiotensin receptor blockers 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 European Medicine Agency declared that 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. For the first time, a green and sensitive HPLC method was developed for the determination of NDEA in LOS & VLS using mobile phase of 0.02M ammonium acetate adjusted to pH 7.2 and ethanol in gradient manner. LOD and LOQ 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 indicate the feasibility of its determination by the proposed conventional method without need for expensive instrumentations that are not available in most of pharmaceutical quality control laboratories. The method was found to have the lowest ecological impact as assessed on the Green Analytical Procedure Index greenness metric and Analytical GREEnness calculator.
Author Related Publications
Magda Mohamed Elsayed Elhenawy, "Application of quality by design approach for HPTLC simultaneous determination of amlodipine and celecoxib in presence of process-related impurity", ELSEVIERRADARWEG 29, 1043 NX AMSTERDAM, NETHERLANDS, 2021
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Magda Mohamed Elsayed Elhenawy, "Smart UV spectrophotometric methods based on simple mathematical filtration and classical methods for the simultaneous determination of tamsulosin and solifenacin: A comparative study of efficacy and spectral resolution", ELSEVIERRADARWEG 29, 1043 NX AMSTERDAM, NETHERLANDS, 2021
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Magda Mohamed Elsayed Elhenawy, "Spectral analysis of severely overlapping spectra based on newly developed mathematical filtration techniques and ratio spectra manipulations: An application to the concurrent determination of dapoxetine and sildenafil in combined dosage form", PERGAMON-ELSEVIER SCIENCE LTD, 2021
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Magda Mohamed Elsayed Elhenawy, "Validation of HPLC-UV Multi-Residue Method for the Simultaneous Determination of Tetracycline, Oxytetracycline, Spiramycin and Neospiramycin in Raw Milk", Springer, 2021
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Magda Mohamed Elsayed Elhenawy, "Carbon nanotubes bulk modified printed electrochemical sensor for green determination of vortioxetine hydrobromide by linear sweep voltammetry", Elsevier, 2021
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Department Related Publications
Hawaa Mohamed Khalil Salem Khalil, "Analytical Study of Protein of Milk & Milk Products ", لايوجد, 1900
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Magda Mohamed Elsayed Elhenawy, " New Methods for the Quantitative Determination of Certain Antihistaminic Drugs&Their Application in Pharmaceutical Preparations ", لايوجد, 1900
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