Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation

The antibiotics Cefoperazone Sodium and Sulbactam Sodium are widely employed in clinical medicine as means to combat many kinds of bacterial infections. The drugs Cefoperazone and Sulbactum shows wavelength at 229 m and 277 nm respectively in solvent of 1 % glycerol, 1 % 0.1 M NaOH in distilled wate...

Full description

Saved in:
Bibliographic Details
Main Authors: Nitin Kumar, Praveen Kumar Kusuma, Bhukya Vijay Nayak, Durga Prasad Beda
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Green Analytical Chemistry
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2772577425000357
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849761536982122496
author Nitin Kumar
Praveen Kumar Kusuma
Bhukya Vijay Nayak
Durga Prasad Beda
author_facet Nitin Kumar
Praveen Kumar Kusuma
Bhukya Vijay Nayak
Durga Prasad Beda
author_sort Nitin Kumar
collection DOAJ
description The antibiotics Cefoperazone Sodium and Sulbactam Sodium are widely employed in clinical medicine as means to combat many kinds of bacterial infections. The drugs Cefoperazone and Sulbactum shows wavelength at 229 m and 277 nm respectively in solvent of 1 % glycerol, 1 % 0.1 M NaOH in distilled water. The methods proposed on UV spectrophotometric technique are the Simultaneous Equation Method, Q-Absorbance Ratio Method, Absorbance Subtraction Method, and the Area Under Curve Method (AUC). Using original stock solutions, their linear range extended from 5 to 25 µg/mL for CEF, and from 10 to 50 µg/mL for SUL with correlation coefficient is greater than 0.99. The methods are validated as per the ICH Q2 (R1) guidelines. The average recovery rates ranging from 100.34 % to 100.92 %. The results demonstrate accuracy, linearity and precision and the methods showed successful application in the quantification of the components under study in the commercially available dosage form with no interference from the matrix excipients. Six green metrics were used to evaluate the environmental impact of the extraction procedure, using Analytical Greenness (AGREE) metric algorithm shows score of 0.83 based on the green analytical chemistry framework. Analytical Eco-Scale scored 92 which is excellent greenness, the method is also assessed with AGREEprep, Complex Green Analytical Procedure Index (Complex GAPI), Assessment of Green Profile (AGP), and National Environmental Methods Index (NEMI) and found greenness compared with the reported method.
format Article
id doaj-art-5d174d8c286f481b957a8849e08bf9d1
institution DOAJ
issn 2772-5774
language English
publishDate 2025-06-01
publisher Elsevier
record_format Article
series Green Analytical Chemistry
spelling doaj-art-5d174d8c286f481b957a8849e08bf9d12025-08-20T03:06:00ZengElsevierGreen Analytical Chemistry2772-57742025-06-011310023910.1016/j.greeac.2025.100239Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluationNitin Kumar0Praveen Kumar Kusuma1Bhukya Vijay Nayak2Durga Prasad Beda3Department of Pharmaceutical Chemistry, School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi 110017, IndiaDepartment of Pharmaceutical Chemistry, School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi 110017, India; Corresponding author.Department of Pharmaceutical Sciences, GITAM School of Pharmacy, GITAM Deemed to be University, Hyderabad, Telangana, IndiaDepartment of Pharmaceutical Sciences, GITAM School of Pharmacy, GITAM Deemed to be University, Hyderabad, Telangana, IndiaThe antibiotics Cefoperazone Sodium and Sulbactam Sodium are widely employed in clinical medicine as means to combat many kinds of bacterial infections. The drugs Cefoperazone and Sulbactum shows wavelength at 229 m and 277 nm respectively in solvent of 1 % glycerol, 1 % 0.1 M NaOH in distilled water. The methods proposed on UV spectrophotometric technique are the Simultaneous Equation Method, Q-Absorbance Ratio Method, Absorbance Subtraction Method, and the Area Under Curve Method (AUC). Using original stock solutions, their linear range extended from 5 to 25 µg/mL for CEF, and from 10 to 50 µg/mL for SUL with correlation coefficient is greater than 0.99. The methods are validated as per the ICH Q2 (R1) guidelines. The average recovery rates ranging from 100.34 % to 100.92 %. The results demonstrate accuracy, linearity and precision and the methods showed successful application in the quantification of the components under study in the commercially available dosage form with no interference from the matrix excipients. Six green metrics were used to evaluate the environmental impact of the extraction procedure, using Analytical Greenness (AGREE) metric algorithm shows score of 0.83 based on the green analytical chemistry framework. Analytical Eco-Scale scored 92 which is excellent greenness, the method is also assessed with AGREEprep, Complex Green Analytical Procedure Index (Complex GAPI), Assessment of Green Profile (AGP), and National Environmental Methods Index (NEMI) and found greenness compared with the reported method.http://www.sciencedirect.com/science/article/pii/S2772577425000357Cefoperazone sodiumSulbactam sodiumUV spectrophotometric techniqueICH GuidelinesGreen analytical chemistry
spellingShingle Nitin Kumar
Praveen Kumar Kusuma
Bhukya Vijay Nayak
Durga Prasad Beda
Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation
Green Analytical Chemistry
Cefoperazone sodium
Sulbactam sodium
UV spectrophotometric technique
ICH Guidelines
Green analytical chemistry
title Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation
title_full Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation
title_fullStr Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation
title_full_unstemmed Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation
title_short Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation
title_sort spectrophotometric method development and validation for simultaneous quantification of cefoperazone and sulbactum sodium in bulk and marketed formulation greenness profile evaluation
topic Cefoperazone sodium
Sulbactam sodium
UV spectrophotometric technique
ICH Guidelines
Green analytical chemistry
url http://www.sciencedirect.com/science/article/pii/S2772577425000357
work_keys_str_mv AT nitinkumar spectrophotometricmethoddevelopmentandvalidationforsimultaneousquantificationofcefoperazoneandsulbactumsodiuminbulkandmarketedformulationgreennessprofileevaluation
AT praveenkumarkusuma spectrophotometricmethoddevelopmentandvalidationforsimultaneousquantificationofcefoperazoneandsulbactumsodiuminbulkandmarketedformulationgreennessprofileevaluation
AT bhukyavijaynayak spectrophotometricmethoddevelopmentandvalidationforsimultaneousquantificationofcefoperazoneandsulbactumsodiuminbulkandmarketedformulationgreennessprofileevaluation
AT durgaprasadbeda spectrophotometricmethoddevelopmentandvalidationforsimultaneousquantificationofcefoperazoneandsulbactumsodiuminbulkandmarketedformulationgreennessprofileevaluation