Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms

Novel, accurate, selective, and rapid high-performance liquid chromatography mass spectrometry method was developed for simultaneous analysis of amoxicillin trihydrate, dicloxacillin sodium, and their official impurity 6-aminopenicillanic acid. The chromatographic separation was carried out by apply...

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Main Authors: Atiah H. Almalki, Essraa A. Hussein, Ibrahim A. Naguib, Eglal A. Abdelaleem, Hala E. Zaazaa, Fatma F. Abdallah
Format: Article
Language:English
Published: Wiley 2021-01-01
Series:Journal of Analytical Methods in Chemistry
Online Access:http://dx.doi.org/10.1155/2021/5570938
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author Atiah H. Almalki
Essraa A. Hussein
Ibrahim A. Naguib
Eglal A. Abdelaleem
Hala E. Zaazaa
Fatma F. Abdallah
author_facet Atiah H. Almalki
Essraa A. Hussein
Ibrahim A. Naguib
Eglal A. Abdelaleem
Hala E. Zaazaa
Fatma F. Abdallah
author_sort Atiah H. Almalki
collection DOAJ
description Novel, accurate, selective, and rapid high-performance liquid chromatography mass spectrometry method was developed for simultaneous analysis of amoxicillin trihydrate, dicloxacillin sodium, and their official impurity 6-aminopenicillanic acid. The chromatographic separation was carried out by applying the mixture on a C18 column (3.5 µm ps, 100 mm × 4.6 mm id) using acetonitrile:water (65 : 35 by volume) as a mobile phase within only 4 min. The quantitative analysis was executed using single quadrupole mass spectrometer in which electrospray ionization, selected ion monitoring, and negative mode were operated. The retention times were 1.61, 2.54, and 3.50 mins for amoxicillin, 6-aminopenicillanic acid, and dicloxacillin, respectively. The method was validated in linear ranges of 2–28 µg mL−1, 2–35 µg mL−1, and 1–10 µg mL−1 for amoxicillin, dicloxacillin, and 6-aminopenicillanic acid, respectively. The results obtained from the suggested HPLC/MS were statistically compared with those obtained from the reported HPLC method, where no significant difference appeared respecting accuracy and precision. According to the analytical eco-scale assessment method, the proposed method was proved to be greener than the reported one, where the analysis time and the amount of the wasted effluent decreased.
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institution Kabale University
issn 2090-8865
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language English
publishDate 2021-01-01
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series Journal of Analytical Methods in Chemistry
spelling doaj-art-f86f5f1fdd8143219b5747b4398c81f42025-02-03T07:23:27ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732021-01-01202110.1155/2021/55709385570938Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage FormsAtiah H. Almalki0Essraa A. Hussein1Ibrahim A. Naguib2Eglal A. Abdelaleem3Hala E. Zaazaa4Fatma F. Abdallah5Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaPharmaceutical Analytical Chemistry Department, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef 62514, EgyptDepartment of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaPharmaceutical Analytical Chemistry Department, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef 62514, EgyptAnalytical Chemistry Department, Pharmacy-Cairo University, Kasr El-Aini, Cairo 11562, EgyptPharmaceutical Analytical Chemistry Department, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef 62514, EgyptNovel, accurate, selective, and rapid high-performance liquid chromatography mass spectrometry method was developed for simultaneous analysis of amoxicillin trihydrate, dicloxacillin sodium, and their official impurity 6-aminopenicillanic acid. The chromatographic separation was carried out by applying the mixture on a C18 column (3.5 µm ps, 100 mm × 4.6 mm id) using acetonitrile:water (65 : 35 by volume) as a mobile phase within only 4 min. The quantitative analysis was executed using single quadrupole mass spectrometer in which electrospray ionization, selected ion monitoring, and negative mode were operated. The retention times were 1.61, 2.54, and 3.50 mins for amoxicillin, 6-aminopenicillanic acid, and dicloxacillin, respectively. The method was validated in linear ranges of 2–28 µg mL−1, 2–35 µg mL−1, and 1–10 µg mL−1 for amoxicillin, dicloxacillin, and 6-aminopenicillanic acid, respectively. The results obtained from the suggested HPLC/MS were statistically compared with those obtained from the reported HPLC method, where no significant difference appeared respecting accuracy and precision. According to the analytical eco-scale assessment method, the proposed method was proved to be greener than the reported one, where the analysis time and the amount of the wasted effluent decreased.http://dx.doi.org/10.1155/2021/5570938
spellingShingle Atiah H. Almalki
Essraa A. Hussein
Ibrahim A. Naguib
Eglal A. Abdelaleem
Hala E. Zaazaa
Fatma F. Abdallah
Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms
Journal of Analytical Methods in Chemistry
title Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms
title_full Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms
title_fullStr Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms
title_full_unstemmed Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms
title_short Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms
title_sort development and validation of ecofriendly hplc ms method for quantitative assay of amoxicillin dicloxacillin and their official impurity in pure and dosage forms
url http://dx.doi.org/10.1155/2021/5570938
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