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Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose

The fixed-dose combination of Amlodipine Besylate (ADB) with Perindopril Tertbutylamine (PTBA) drug is used to treat patients with mild-to-moderate hypertension. In recent times researchers are interested to find the efficient analytical method development and validation for the simultaneous determi...

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Autores principales: Khan, Muhammad Farooq Saleem, Tahir, Lutafullah, Zhou, Xu, Bary, Ghulam, Sajid, Muhammad, Shahzad, Ahmad Khawar, Khan, Ilyas, Mohamed, Abdullah, Ahmad, Riaz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10009730/
https://www.ncbi.nlm.nih.gov/pubmed/36923897
http://dx.doi.org/10.1016/j.heliyon.2023.e14209
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author Khan, Muhammad Farooq Saleem
Tahir, Lutafullah
Zhou, Xu
Bary, Ghulam
Sajid, Muhammad
Shahzad, Ahmad Khawar
Khan, Ilyas
Mohamed, Abdullah
Ahmad, Riaz
author_facet Khan, Muhammad Farooq Saleem
Tahir, Lutafullah
Zhou, Xu
Bary, Ghulam
Sajid, Muhammad
Shahzad, Ahmad Khawar
Khan, Ilyas
Mohamed, Abdullah
Ahmad, Riaz
author_sort Khan, Muhammad Farooq Saleem
collection PubMed
description The fixed-dose combination of Amlodipine Besylate (ADB) with Perindopril Tertbutylamine (PTBA) drug is used to treat patients with mild-to-moderate hypertension. In recent times researchers are interested to find the efficient analytical method development and validation for the simultaneous determination of ADB and PTBA in a fixed-dose, film-coated tablet. Therefore, the current study was performed with a reverse-phase liquid chromatography method developed to simultaneously analyze ADB and PTBA in film-coated tablets as fixed-dose combinations. The linearity of the proposed method was calculated by preparing six different mixtures of both ADB and PTBA in the mobile phase. The concentration of both the analytes was analyzed at 56mg/100 mL to 84mg/100 mL and 32mg/100 mL to 48mg/100 mL, respectively. The ratio of acetonitrile and phosphate buffer was 35:65. The flow rate was adjusted to 1.5 ml per minute to reduce the retention time. The validation study was performed for the parameters specificity, linearity, precision, range, limit of detection, limit of quantification, accuracy/biasness, and robustness. The relative percentage standard deviation for Perindopril Tertbutyl amine was 0.148%, and for Amlodipine is 0.312%. These results show that the advanced analysis method for simultaneous analysis of fixed-dose is precise. The theoretical IR spectra were also calculated by Gaussian 9.2 by employing the B3LYP functional at density functional theory (DFT) level study. All these parameters studied in this work authenticate the effectiveness of the developed validation method and ensure its repeatability/reproducibility accordingly. To the best of our knowledge, this is the first time to develop a new fast, and easy method for simultaneous identification and quantification of ADB and PTBA by high-performance liquid chromatography (HPLC) with a time-efficient and cost-effective approach.
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spelling pubmed-100097302023-03-14 Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose Khan, Muhammad Farooq Saleem Tahir, Lutafullah Zhou, Xu Bary, Ghulam Sajid, Muhammad Shahzad, Ahmad Khawar Khan, Ilyas Mohamed, Abdullah Ahmad, Riaz Heliyon Research Article The fixed-dose combination of Amlodipine Besylate (ADB) with Perindopril Tertbutylamine (PTBA) drug is used to treat patients with mild-to-moderate hypertension. In recent times researchers are interested to find the efficient analytical method development and validation for the simultaneous determination of ADB and PTBA in a fixed-dose, film-coated tablet. Therefore, the current study was performed with a reverse-phase liquid chromatography method developed to simultaneously analyze ADB and PTBA in film-coated tablets as fixed-dose combinations. The linearity of the proposed method was calculated by preparing six different mixtures of both ADB and PTBA in the mobile phase. The concentration of both the analytes was analyzed at 56mg/100 mL to 84mg/100 mL and 32mg/100 mL to 48mg/100 mL, respectively. The ratio of acetonitrile and phosphate buffer was 35:65. The flow rate was adjusted to 1.5 ml per minute to reduce the retention time. The validation study was performed for the parameters specificity, linearity, precision, range, limit of detection, limit of quantification, accuracy/biasness, and robustness. The relative percentage standard deviation for Perindopril Tertbutyl amine was 0.148%, and for Amlodipine is 0.312%. These results show that the advanced analysis method for simultaneous analysis of fixed-dose is precise. The theoretical IR spectra were also calculated by Gaussian 9.2 by employing the B3LYP functional at density functional theory (DFT) level study. All these parameters studied in this work authenticate the effectiveness of the developed validation method and ensure its repeatability/reproducibility accordingly. To the best of our knowledge, this is the first time to develop a new fast, and easy method for simultaneous identification and quantification of ADB and PTBA by high-performance liquid chromatography (HPLC) with a time-efficient and cost-effective approach. Elsevier 2023-03-01 /pmc/articles/PMC10009730/ /pubmed/36923897 http://dx.doi.org/10.1016/j.heliyon.2023.e14209 Text en © 2023 The Authors. Published by Elsevier Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Research Article
Khan, Muhammad Farooq Saleem
Tahir, Lutafullah
Zhou, Xu
Bary, Ghulam
Sajid, Muhammad
Shahzad, Ahmad Khawar
Khan, Ilyas
Mohamed, Abdullah
Ahmad, Riaz
Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose
title Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose
title_full Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose
title_fullStr Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose
title_full_unstemmed Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose
title_short Method development for simultaneous estimation of Amlodipine Besylate and Perindopril Tertbutyl amine in fixed-dose
title_sort method development for simultaneous estimation of amlodipine besylate and perindopril tertbutyl amine in fixed-dose
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10009730/
https://www.ncbi.nlm.nih.gov/pubmed/36923897
http://dx.doi.org/10.1016/j.heliyon.2023.e14209
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