Microbial agar assay for prulifloxacin stability testing validated.
Journal name: World Journal of Pharmaceutical Research
Original article title: Validated stability indicating microbial agar assay method for determination of prulifloxacin
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Sweety Kanolkar, Teja Walke, Yogita Sardessai
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Validated stability indicating microbial agar assay method for determination of prulifloxacin
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
Prulifloxacin is an emerging fluoroquinolone antibiotic known for its effectiveness against a wide range of gram-positive and gram-negative bacteria. As a prodrug, it metabolizes in the body to its active form, ulifloxacin. The drug has been approved for treating various infections, including urinary tract infections and gastroenteritis. Despite its clinical significance, existing literature indicates a lack of stability-indicating microbial agar assay methods for Prulifloxacin. This study aimed to develop and validate a specific agar diffusion bioassay employing the strain Salmonella typhimurium ATCC 23564 to ensure reliable quantification of Prulifloxacin in pharmaceutical formulations.
Validated Microbial Agar Assay
The development of a microbial agar assay was executed with rigorous validation processes encompassing linearity, precision, and accuracy. The method demonstrated a linear relationship when measuring the diameter of the inhibition zone with varying concentrations of Prulifloxacin, ranging from 20 to 60 µg/mL. The regression analysis indicated a high correlation coefficient of 0.997, asserting the method's reliability. Furthermore, the assay proved precise, with relative standard deviation (RSD) values indicating both repeatability and method precision across multiple days. This validation underscores the assay's potential for routine quality control in pharmaceutical applications.
Stress Degradation Studies
An essential aspect of the study involved conducting stress degradation tests, such as thermal stress, photo degradation, acid degradation, and alkaline degradation. The findings revealed significant degradation of Prulifloxacin under varying conditions, with photo degradation showing the highest degradation rate of 84.34%. Acid degradation followed closely at 88.31%, while thermal and alkaline conditions resulted in 65.12% degradation. These results provide insights into the drug's stability and underscore the importance of employing stability-indicating methods in assessing its integrity in pharmaceutical formulations.
Method Implementation and Application
The agar diffusion bioassay developed in this study is characterized by its simplicity and cost-effectiveness, utilizing readily available reagents and requiring minimal sample preparation. This method is particularly advantageous for routine analysis of Prulifloxacin in compounded pharmaceutical dosage forms. Given the demonstrated precision and accuracy of this bioassay, it represents a viable alternative to existing analytical methods, enhancing the capacity for stability assessments and quality assurance in pharmaceutical settings.
Conclusion
In conclusion, the validated microbial agar assay for Prulifloxacin presents a reliable and accessible method for assessing the drug's stability in pharmaceutical formulations. The study's thorough validation, encompassing linearity, precision, and stress degradation evaluation, confirms the method's efficacy for routine quality control. As the need for effective and reliable analytical techniques grows in the pharmaceutical industry, the proposed bioassay offers significant promise for ensuring the safety and efficacy of Prulifloxacin in therapeutic applications.
FAQ section (important questions/answers):
What is the purpose of the microbial agar assay in this study?
The microbial agar assay aims to determine the stability and quantification of Prulifloxacin using the strain Salmonella typhimurium. This validated bioassay can serve as an alternative analytical method for assessing drug stability.
What methodologies were compared to the agar diffusion assay for Prulifloxacin?
Literature survey revealed methodologies such as UV-Visible spectrophotometry, LC-MS/MS, and RP-HPLC. However, these methods do not include stability indicating agar diffusion assays, which this study focuses on developing.
What degradation conditions were tested for Prulifloxacin stability?
The study tested Prulifloxacin under various stress conditions, including thermal stress, acid and alkaline hydrolysis, and UV radiation at 254 nm, to evaluate its degradation and stability.
How was the accuracy of the bioassay determined?
Accuracy was assessed through percent recovery studies. The study involved adding a known amount of standard drug at different levels (80%, 100%, 120%) to the sample, with an average recovery of 95.37%.
What microorganism was used in the bioassay and why?
Salmonella typhimurium ATCC 23564 was chosen due to its susceptibility to Prulifloxacin and its ability to form clearly defined zones of inhibition, which are crucial for precision in measurements.
What are the key findings from the stress degradation studies?
The results indicated significant degradation of Prulifloxacin under various conditions: 65.12% under thermal stress, 84.34% from photo degradation, and 88.31% from acid degradation, highlighting its instability under stress.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Microbial agar assay for prulifloxacin stability testing validated.”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
The term 'Drug' refers to a substance used for medical purposes. In this context, Prulifloxacin is identified as a new fluoroquinolone antibiotic. It highlights its importance in treating infections and signifies the drug's biochemical interactions and therapeutic potentials in combating bacterial diseases, particularly emphasizing its role in the study.
2) Table:
In scientific research, a 'Table' is used to present data systematically. Here, tables are employed to summarize findings, such as zone diameters and precision results. This aids in visual clarity and facilitates easier comparison of results, which is critical in validating the methods and ensuring reliability in research.
3) India:
India is relevant as the geographic location where the research was conducted. It underscores the necessity for studies on pharmaceuticals within diverse populations and provides insights into local pharmaceutical practices. The study's findings contribute to national healthcare, paving the way for improved therapeutic strategies against bacterial infections in India.
4) Relative:
The term 'Relative' pertains to a comparative measurement in the context of data validation, particularly in precision analysis. It describes the assessment of variability in repeated measurements, especially expressed as Relative Standard Deviation (RSD), which is crucial in establishing method reliability and demonstrating consistent performance in biological assays.
5) Quality:
Quality refers to the standard of the analytical methods utilized in this study. The focus on the 'Department of Quality Assurance' suggests an emphasis on ensuring the accuracy, reliability, and reproducibility of the agar diffusion bioassay. Quality assurance processes are essential for validating pharmaceutical analyses and ensuring drug safety.
6) Study (Studying):
A 'Study' refers to a systematic investigation aimed at acquiring knowledge about a specific topic. In this context, the study on Prulifloxacin serves to develop and validate a microbial agar assay to quantify the drug amidst various stress conditions, contributing significant findings to the fields of microbiology and pharmacology.
7) Performance:
Performance in this context relates to the assay's capability to effectively measure Prulifloxacin. It encompasses various factors including precision, accuracy, and reliability of the method. The performance evaluation ensures that the assay can consistently produce valid results, which is essential for its acceptance in scientific and regulatory standards.
8) Measurement:
Measurement is crucial in research, involving quantification of variables. Specifically, it pertains to determining the inhibition zone diameters in the agar diffusion bioassay. Accurate measurement ensures the validity of the results, directly influencing the interpretation of the drug's efficacy and stability under various conditions of degradation.
9) Discussion:
The 'Discussion' section in research articles provides an analysis of the findings. Here, it interprets the results obtained from the bioassay in relation to existing literature. This interpretation contextualizes the significance of the data, facilitating a comprehensive understanding of the implications and potential future directions for the research.
10) Substance:
In the paper, 'Substance' refers to the active pharmaceutical ingredient, Prulifloxacin. It is essential for understanding drug properties, effects, and behavior under different conditions. The characterization of the substance is paramount in pharmaceuticals, as it influences formulation development, stability studies, and therapeutic efficacy against bacterial infections.
11) Activity:
The term 'Activity' signifies the biological effectiveness of Prulifloxacin against pathogens. In the study, activity is assessed through the agar diffusion method, which establishes the drug's potency through the measurement of inhibition zones. This information is critical for evaluating its clinical applications and determining suitable therapeutic dosages.
12) Medium:
Medium refers to the agar and broth used in microbial assays. In this study, Muller Hinton Agar is utilized as the growth medium for Salmonella typhimurium. The right medium is vital for supporting bacterial growth and ensuring accurate bioassay results, reinforcing the method's validity in drug analysis.
13) Powder:
Powder in this context relates to the formulation of Prulifloxacin tablets. It highlights the significance of proper sample preparation by crushing tablets into a powder before analysis. This step is necessary to obtain uniformity in the sample, ensuring reliable results during the microbial agar assay process.
14) Filling (Filled):
'Filled' pertains to the act of introducing the drug solution into wells of the agar plate during the assay. This is a critical step in the methodology as it ensures a proper evaluation of the drug's antimicrobial properties. Proper filling techniques are vital for avoiding variability in the results.
15) Pune:
Pune is mentioned in conjunction with National Chemical Laboratory, which indicates its relevance in providing the necessary bacterial strains for this research. This highlights the importance of regional facilities in scientific studies, promoting collaboration between institutions to enhance pharmaceutical research capabilities within India.
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