Anil Kumar Teotia Principal Scientific Officer, Microbiology Division, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, Uttar Pradesh 201002, Government of India, India
Bhavna Kumari Pharmacopoeial Associate, Microbiology Division,Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, Uttar Pradesh 201002, Government of India, India
Prasad Thota Scientific Officer, Microbiology Division, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, Uttar Pradesh 201002, Government of India, India
Piyush Kumar Pharmacopoeial Scientist, Microbiology Division,Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, Uttar Pradesh 201002, Government of India, India
Manoj Kumar Pandey Senior Scientific Officer, Microbiology Division, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, Uttar Pradesh 201002, Government of India, India
Rajeev Singh Raghuvanshi Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, Uttar Pradesh 201002, Government of India, India
Address for correspondence: Anil Kumar Teotia, Principal Scientific Officer, Microbiology Division, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, Uttar Pradesh 201002, Government of India, India E-mail: akteotia.ipc@gov.in
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Bhavna Kumari, Anil Kumar Teotia, Prasad Thota, et al./Assessment of the Potency of Ceftiofur Sodium Powder through Validated Microbiological Method/J Forensic Chemistry Toxicol. 2022;8(2):53–61.
Timeline
Received : March 21, 2022
Accepted : April 22, 2022
Published : December 25, 2022
Abstract
Ceftiofur Sodium is a semi-synthetic beta-lactamase broad spectrum third generation of cephalosporin antibiotic. The development and validation of a two-level agar diffusion (2+2) bioassay to quantify ceftiofur in powder for injection is described in this paper. Bacterial strain Bacillus subtilis ATCC 6633 (MTCC 441) was selected and used as the most significant strain against ceftiofur sodium. The mean potency recovery value of ceftiofur sodium in marketed sample XCEFT powder for injection was estimated to be 101.79%. All potency results were statistically analyzed and found to be linear (r2 = 0.9916) in the range of 1.0-10 µgmL-1, with the intermediate precision RSD between days was 0.81%; intermediate precision RSD between analyst was 0.43% and accuracy 101.08%, RSD = 0.28%. The findings backed up the proposed microbiological technique, which allowed for accurate ceftiofur sodium quantification in pharmaceutical samples. Furthermore, bioassay is a useful, easy and cost-effective method for controlling the quality of ceftiofur sodium in raw material as well as in pharmaceutical preparations.
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Data Sharing Statement
There are no additional data available. All raw data and code are available upon request.
Funding
This research received no funding.
Author Contributions
All authors contributed significantly to the work and approve its publication.
Ethics Declaration
This article does not involve any human or animal subjects, and therefore does not require ethics approval.
Acknowledgements
We would like to express our gratitude to the patients, their families, and all those who have contributed to this study.
Conflicts of Interest
No conflicts of interest in this work.
About this article
Cite this article
Bhavna Kumari, Anil Kumar Teotia, Prasad Thota, et al./Assessment of the Potency of Ceftiofur Sodium Powder through Validated Microbiological Method/J Forensic Chemistry Toxicol. 2022;8(2):53–61.
This license enables
reusers to distribute, remix, adapt, and build upon the material in any medium
or format for noncommercial purposes only, and only so long as attribution is
given to the creator.
This license enables
reusers to distribute, remix, adapt, and build upon the material in any medium
or format for noncommercial purposes only, and only so long as attribution is
given to the creator.
Description: Chemical Structure of Ceftiofur sodium
Heading
Description: Two level agar diffusion assay method using a test
microorganism Bacillus subtilis ATCC-6633 (MTCC 441) at
concentration of Reference solution SH = 4 µgmL-1, SL = 1
µgmL-1 and Sample solution SH = 4 µgmL-1, SL = µgmL-1)
Heading
Description: Selection of most suitable microbes for microbiological assay of ceftiofur sodium
Heading
Description: Action of different inoculum concentration on the area of growth inhibition zones
Heading
Description: Bioassay derived calibration curve for ceftiofur sodium reference substance
Heading
Description: Effect of ceftiofur reference substance concentrations on inhibition zone
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Description: Repeatability evaluation for XCEFT powder for injection by bioassay
Heading
Description: Intermediate precision evaluation for XCEFT powder for injection by bioassay.
Heading
Description: Accuracy for XCEFT powder for injection by bioassay