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A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension

A new reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of pediatric oral powder formulation containing cefixime (CFX) and clavulanic acid (CVA). In this research, an analytical C18 (4.6 mm × 25 cm), 5 μm column was used...

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Detalles Bibliográficos
Autores principales: Nepal, Utsav, Panthi, Vijay Kumar, Chaudhary, Namindra Prasad, Chaudhary, Samip
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9270147/
https://www.ncbi.nlm.nih.gov/pubmed/35814262
http://dx.doi.org/10.1155/2022/8331762
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author Nepal, Utsav
Panthi, Vijay Kumar
Chaudhary, Namindra Prasad
Chaudhary, Samip
author_facet Nepal, Utsav
Panthi, Vijay Kumar
Chaudhary, Namindra Prasad
Chaudhary, Samip
author_sort Nepal, Utsav
collection PubMed
description A new reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of pediatric oral powder formulation containing cefixime (CFX) and clavulanic acid (CVA). In this research, an analytical C18 (4.6 mm × 25 cm), 5 μm column was used for chromatographic separation with a mixture of methanol and water containing disodium hydrogen phosphate in ratio of 20 : 80 v/v as the mobile phase (pH 5.5 adjusted with orthophosphoric acid) at a flow rate of 1.0 mL/min. The detecting wavelength and run time were 220 nm and 15 min, respectively. Moreover, the column temperature was maintained at 30°C. The analytical method was validated prior to meeting the conditions specified by International Conference on Harmonization (ICH) and the parameters were specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness, and solution stability. The calibration curve was found to be linear between the concentration ranges of 0.024–0.036 mg/mL and 0.032–0.048 mg/mL for CFX and CVA, respectively. Furthermore, the LOD and LOQ of CFX were 0.0008 and 0.0025 μg/mL, respectively. Accordingly, LOD and LOQ of CVA were 0.0021 and 0.0065 μg/mL, respectively. The accuracy of the optimized method was examined by recovery studies and the mean recovery was observed to be 98.96% and 99.05% for CFX and CVA, respectively, at 100% spiked level. The repeatability testing for both standard and sample solutions revealed that the method is precise within the acceptable range and the %RSD of the precision was <2%. In addition, the findings of specificity, linearity, accuracy, precision, robustness, LOD, LOQ, and solution stability studies of both CFX and CVA were within the criteria of acceptable limit as well.
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spelling pubmed-92701472022-07-09 A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension Nepal, Utsav Panthi, Vijay Kumar Chaudhary, Namindra Prasad Chaudhary, Samip Int J Anal Chem Research Article A new reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of pediatric oral powder formulation containing cefixime (CFX) and clavulanic acid (CVA). In this research, an analytical C18 (4.6 mm × 25 cm), 5 μm column was used for chromatographic separation with a mixture of methanol and water containing disodium hydrogen phosphate in ratio of 20 : 80 v/v as the mobile phase (pH 5.5 adjusted with orthophosphoric acid) at a flow rate of 1.0 mL/min. The detecting wavelength and run time were 220 nm and 15 min, respectively. Moreover, the column temperature was maintained at 30°C. The analytical method was validated prior to meeting the conditions specified by International Conference on Harmonization (ICH) and the parameters were specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness, and solution stability. The calibration curve was found to be linear between the concentration ranges of 0.024–0.036 mg/mL and 0.032–0.048 mg/mL for CFX and CVA, respectively. Furthermore, the LOD and LOQ of CFX were 0.0008 and 0.0025 μg/mL, respectively. Accordingly, LOD and LOQ of CVA were 0.0021 and 0.0065 μg/mL, respectively. The accuracy of the optimized method was examined by recovery studies and the mean recovery was observed to be 98.96% and 99.05% for CFX and CVA, respectively, at 100% spiked level. The repeatability testing for both standard and sample solutions revealed that the method is precise within the acceptable range and the %RSD of the precision was <2%. In addition, the findings of specificity, linearity, accuracy, precision, robustness, LOD, LOQ, and solution stability studies of both CFX and CVA were within the criteria of acceptable limit as well. Hindawi 2022-07-01 /pmc/articles/PMC9270147/ /pubmed/35814262 http://dx.doi.org/10.1155/2022/8331762 Text en Copyright © 2022 Utsav Nepal et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Nepal, Utsav
Panthi, Vijay Kumar
Chaudhary, Namindra Prasad
Chaudhary, Samip
A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension
title A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension
title_full A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension
title_fullStr A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension
title_full_unstemmed A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension
title_short A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension
title_sort validated rp-hplc method for simultaneous determination of cefixime and clavulanic acid powder in pediatric oral suspension
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9270147/
https://www.ncbi.nlm.nih.gov/pubmed/35814262
http://dx.doi.org/10.1155/2022/8331762
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