COMPARISON AND EVALUATION OF PHARMACOPOEIAL METHODS FOR THE ASSESSMENT OF POTENCY OF ANTIBIOTICS

  • Gökhan CENGİZ Ministry of Health, Turkish Medicines and Medical Devices Agency, Analysis and Control Laboratories Department, Ankara, Turkey.
  • Evren ALGIN YAPAR Ministry of Health, Turkish Medicines and Medical Devices Agency, Department of Analysis and Control Laboratories, Ankara, Turkey.
  • Bilge Ahsen KARA Ministry of Health, Ankara Gazi Mustafa Kemal State Hospital, Ankara, Turkey.
  • Rakesh K. SINDHU Chitkara University, Chitkara College of Pharmacy, Punjab, India.

Abstract

The detection and assessment of potency of antibiotics are crucial for the pharmaceutics. The valid methods for microbiological assays in pharmacopoeias are mainly based on statistical comparison of the data obtained by measuring the cidal activity resulting from the treatment of the antibiotic active ingredient in the composition of the pharmaceutics with the target microorganism. However, it was seen that there is no validated microbiological method for some active ingredients. Due to microbiological assays are indispensable methods for determining the potency of some active ingredient groups, the calculation of the potency is performed logarithmically. In either turbidimetric or chromatographic methods, the statistical evaluation of the sample is compared with the standard reference material. Analysis data obtained by chromatographic and chemical methods are linear peak areas and spectrophotometer readings. In microbiological methods, the data obtained from the analyzes performed to determine the potency of antibiotics are the inhibition zone diameters or turbidimetric turbidity data. In this study, above-mentioned microbiological assays are compared in the context of the main pharmacopoeias EP, USP, CP, IP and BP, and evaluated in terms of the chromatographic method and classical microbiological method. It has been observed that chromatographic and chemical methods are not available to determine the potency of some pharmaceutical products containing antibiotics. The examinations made reveal the difficulty of analyzing some active ingredient groups according to chemical and chromatographic methods. For this reason, the importance of method validation studies is increasing in order to analyze active substances that do not have alternative analysis methods with microbiological and chemical methods. In this study, all validated microbiological methods were investigated, and it was aimed to determine alternative methods to chromatographic and chemical methods. It was concluded that the realization of new microbiological methods to be validated by evaluating the methods in all differences would facilitate the study.


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Peer Review History:


Received: 18 May 2021; Revised: 15 June; Accepted: 28 June, Available online: 15 July 2021


Academic Editor: Dr. Asia Selman Abdullahorcid22.jpg,  Al-Razi university, Department of Pharmacy, Yemen, asia_abdullah65@yahoo.com


UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. 


Received file:blue_23983.gif                Reviewer's Comments:download_logo_r_29189.gif


Average Peer review marks at initial stage: 6.5/10


Average Peer review marks at publication stage: 7.5/10


Reviewer(s) detail:


Dr. Iman Muhammad Higazyorcid22.jpg, National Research Center, Egypt, imane.higazy@hotmail.com


Dr. George Zhuorcid22.jpg, Tehran University of Medical Sciences, Tehran, Iran, sansan4240732@163.com


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Keywords: Antibiotics, microbiological assay, pharmaceutics, pharmacopoeial methods, potency

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How to Cite
CENGİZ, G., E. A. YAPAR, B. A. KARA, and R. K. SINDHU. “COMPARISON AND EVALUATION OF PHARMACOPOEIAL METHODS FOR THE ASSESSMENT OF POTENCY OF ANTIBIOTICS”. Universal Journal of Pharmaceutical Research, Vol. 6, no. 3, July 2021, doi:https://doi.org/10.22270/ujpr.v6i3.604.
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