Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities

Abstract Cefoperazone (Cfz) is a member of the third generation of parenteral cephalosporin antibiotics. It is used on a wide scale in prescribed antibiotic drugs as anti-infection, especially for Gram-negative and also against Gram-positive microorganisms. The current study aimed to find a rapid RP...

Full description

Bibliographic Details
Main Authors: Mostafa F. Al-Hakkani, Nourhan Ahmed, Alaa A. Abbas, Mohammad H. A. Hassan
Format: Article
Language:English
Published: BMC 2023-07-01
Series:BMC Chemistry
Subjects:
Online Access:https://doi.org/10.1186/s13065-023-00989-0
_version_ 1797779078948847616
author Mostafa F. Al-Hakkani
Nourhan Ahmed
Alaa A. Abbas
Mohammad H. A. Hassan
author_facet Mostafa F. Al-Hakkani
Nourhan Ahmed
Alaa A. Abbas
Mohammad H. A. Hassan
author_sort Mostafa F. Al-Hakkani
collection DOAJ
description Abstract Cefoperazone (Cfz) is a member of the third generation of parenteral cephalosporin antibiotics. It is used on a wide scale in prescribed antibiotic drugs as anti-infection, especially for Gram-negative and also against Gram-positive microorganisms. The current study aimed to find a rapid RP-HPLC method of Cfz analysis with high linearity, repeatability, sensitivity, selectivity, and inexpensive. In our developed method, there is no need to use special chemical reagents, a high percentage of organic solvent, a high flow rate, further guard column. The chromatographic system comprises an ODS column (150 mm × 4.6 mm × 5 μm). The mobile phase was prepared by mixing KH2PO4 solution: acetonitrile (80:20) with a flow rate of 1.0 mL/min at detection wavelength 230 nm, at room temperature using injection volume 20 μL. The method manifested a satisfied linearity regression R2 (0.9993) with a good repeatability range (0.34–0.92%) with LOD and LOQ; 4.04 μg/mL and 12.24 μg/mL respectively. The method proved its efficiency via system suitability achievement in the robustness and ruggedness conduction according to the validation guidelines. The shorter analysis time makes the method very valuable in quality control to quantify the commercial Cfz in pharmaceutical preparations. This improved HPLC method has been successfully applied for Cfz analysis for Peracef and Peractam vials in our routine finished and stability studies testing laboratories. Additionally, the detection limit of Cfz has been tested in our quality control lab to detect the smallest amount of traces that may be present after the cleaning process of the production machines for cephalosporins preparations. In a precedent for the first time, we were able to use the current analysis method to determine the minimum inhibitory concentration (MIC) and minimum bacteriostatic concentration (MBC). The conventional broth micro-dilution tube method was used to determine MIC at 250 µg/mL and MBC at 125 µg/mL of Cfz against the standard strain of Burkholderia cepacia (B. cepacia) ATCC 25416 as Gram-negative bacteria in vitro.
first_indexed 2024-03-12T23:26:34Z
format Article
id doaj.art-d44fef1a931b40b0893f77e6f7fe2dd8
institution Directory Open Access Journal
issn 2661-801X
language English
last_indexed 2024-03-12T23:26:34Z
publishDate 2023-07-01
publisher BMC
record_format Article
series BMC Chemistry
spelling doaj.art-d44fef1a931b40b0893f77e6f7fe2dd82023-07-16T11:08:28ZengBMCBMC Chemistry2661-801X2023-07-0117111110.1186/s13065-023-00989-0Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activitiesMostafa F. Al-Hakkani0Nourhan Ahmed1Alaa A. Abbas2Mohammad H. A. Hassan3Department of Chemistry, Faculty of Science, Al-Azhar University, Assiut BranchDepartment of Research, Development, and Stability, UP PharmaDepartment of Research, Development, and Stability, UP PharmaDepartment of Medical Laboratory Technology, Higher Technological Institute for Applied Health Sciences in MinyaAbstract Cefoperazone (Cfz) is a member of the third generation of parenteral cephalosporin antibiotics. It is used on a wide scale in prescribed antibiotic drugs as anti-infection, especially for Gram-negative and also against Gram-positive microorganisms. The current study aimed to find a rapid RP-HPLC method of Cfz analysis with high linearity, repeatability, sensitivity, selectivity, and inexpensive. In our developed method, there is no need to use special chemical reagents, a high percentage of organic solvent, a high flow rate, further guard column. The chromatographic system comprises an ODS column (150 mm × 4.6 mm × 5 μm). The mobile phase was prepared by mixing KH2PO4 solution: acetonitrile (80:20) with a flow rate of 1.0 mL/min at detection wavelength 230 nm, at room temperature using injection volume 20 μL. The method manifested a satisfied linearity regression R2 (0.9993) with a good repeatability range (0.34–0.92%) with LOD and LOQ; 4.04 μg/mL and 12.24 μg/mL respectively. The method proved its efficiency via system suitability achievement in the robustness and ruggedness conduction according to the validation guidelines. The shorter analysis time makes the method very valuable in quality control to quantify the commercial Cfz in pharmaceutical preparations. This improved HPLC method has been successfully applied for Cfz analysis for Peracef and Peractam vials in our routine finished and stability studies testing laboratories. Additionally, the detection limit of Cfz has been tested in our quality control lab to detect the smallest amount of traces that may be present after the cleaning process of the production machines for cephalosporins preparations. In a precedent for the first time, we were able to use the current analysis method to determine the minimum inhibitory concentration (MIC) and minimum bacteriostatic concentration (MBC). The conventional broth micro-dilution tube method was used to determine MIC at 250 µg/mL and MBC at 125 µg/mL of Cfz against the standard strain of Burkholderia cepacia (B. cepacia) ATCC 25416 as Gram-negative bacteria in vitro.https://doi.org/10.1186/s13065-023-00989-0AntimicrobialCefoperazoneDetectionQuantitationStability
spellingShingle Mostafa F. Al-Hakkani
Nourhan Ahmed
Alaa A. Abbas
Mohammad H. A. Hassan
Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities
BMC Chemistry
Antimicrobial
Cefoperazone
Detection
Quantitation
Stability
title Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities
title_full Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities
title_fullStr Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities
title_full_unstemmed Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities
title_short Cefoperazone rapidly and sensitive quantitative assessment via a validated RP-HPLC method for different dosage forms, in-use stability, and antimicrobial activities
title_sort cefoperazone rapidly and sensitive quantitative assessment via a validated rp hplc method for different dosage forms in use stability and antimicrobial activities
topic Antimicrobial
Cefoperazone
Detection
Quantitation
Stability
url https://doi.org/10.1186/s13065-023-00989-0
work_keys_str_mv AT mostafafalhakkani cefoperazonerapidlyandsensitivequantitativeassessmentviaavalidatedrphplcmethodfordifferentdosageformsinusestabilityandantimicrobialactivities
AT nourhanahmed cefoperazonerapidlyandsensitivequantitativeassessmentviaavalidatedrphplcmethodfordifferentdosageformsinusestabilityandantimicrobialactivities
AT alaaaabbas cefoperazonerapidlyandsensitivequantitativeassessmentviaavalidatedrphplcmethodfordifferentdosageformsinusestabilityandantimicrobialactivities
AT mohammadhahassan cefoperazonerapidlyandsensitivequantitativeassessmentviaavalidatedrphplcmethodfordifferentdosageformsinusestabilityandantimicrobialactivities