A simple, precise and accurate spectrophotometric method have been developed and validated for the estimation of Enrofloxacin in bulk as well as tablet formulation. The UV spectra of Enrofloxacin was obtained in 0.1N HCl and 0.1N NaOH, and the overlain spectra showed maximum absorbance at 271.0 nm (maxima) and 276.5 nm (minima) in 0.1N NaOH and HCl respectively. The drug follows linearity in the range of 5-30 µg/ml (R2= 0.988). Both intra- and inter-day precision showed % RSD˂ 2 while LOD and LOQ were 0.320 and 0.971 respectively. The method was validated as per ICH guidelines.
Enrofloxacin or [1-cyclopropyl-6-fluoro-7-(4-ethyl-1-piperazinyl)-1,4-dihydro-4-oxo-3 quinoline carboxylic acid]. The chemical structure of the drug is given in. It is a synthetic antibacterial agent from the class of the fluroquinolone carboxylic acid derivatives. It has antibacterial activity against a broad spectrum of Gram negative and Gram positive bacteria. Enrofloxacin is used for the treatment of individual pets and domestic animals.
Literature survey shows that several analytical methods for the determination of Enrofloxacin include RP-HPLC, HPLC, RP-LC, LC and dissolution study have been reported. Many pharmaceutical products have been assayed by this method. But Differential UV spectrophotometric method of Enrofloxacin was not reported as so far. So an attempt was made to develop a novel, simple, accurate spectrophotometric method for the determination of Enrofloxacin in tablet formulation.
Inhaltsverzeichnis (Table of Contents)
- Abstract
- Introduction
- Materials and Methods
- Preparation of standard stock solution
- Preparation of Calibration Curve
- Assay of Tablet Formulation
- Method validation
- Results and Discussion
- Acknowledgments
- References
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
The objective of this work was to develop and validate a simple, precise, and accurate spectrophotometric method for the estimation of Enrofloxacin in bulk and tablet formulations. This involved establishing a reliable analytical technique that adheres to ICH guidelines.
- Development of a differential UV spectrophotometric method for Enrofloxacin assay.
- Validation of the method according to ICH guidelines.
- Application of the method to determine Enrofloxacin in tablet formulations.
- Comparison with existing analytical methods for Enrofloxacin determination.
- Assessment of the method's precision, accuracy, limit of detection (LOD), and limit of quantitation (LOQ).
Zusammenfassung der Kapitel (Chapter Summaries)
Abstract: This abstract describes a newly developed and validated spectrophotometric method for determining Enrofloxacin levels in both bulk and tablet form. The method utilizes the differential absorbance of Enrofloxacin at specific wavelengths in acidic and basic solutions. Linearity, precision (intra- and inter-day), limit of detection (LOD), and limit of quantitation (LOQ) were determined and met validation criteria.
Introduction: This chapter introduces Enrofloxacin, a fluoroquinolone antibacterial agent, detailing its chemical structure and broad-spectrum activity against Gram-positive and Gram-negative bacteria. The chapter highlights the existing analytical methods for Enrofloxacin determination (e.g., RP-HPLC, HPLC, RP-LC, LC, dissolution studies) and notes the lack of previously reported differential UV spectrophotometric methods, thus justifying the development of the novel method presented in this work.
Materials and Methods: This section outlines the materials and equipment used, including the spectrophotometer, balance, and ultrasonic cleaner. It details the preparation of the standard stock solution, the creation of a calibration curve using various concentrations of Enrofloxacin in acidic and basic solutions, and the procedure for assaying Enrofloxacin in tablet formulations using a validated method. The method validation procedures (linearity, accuracy, precision, LOD, and LOQ) performed according to ICH guidelines are described.
Results and Discussion: This chapter presents the findings from the method validation and the application of the developed method to Enrofloxacin tablets. Specific values for linearity, precision (expressed as %RSD), LOD, and LOQ are provided and discussed. The differential spectrophotometry approach, using the difference in absorbance between acidic and basic solutions, is explained and its effectiveness in the assay of Enrofloxacin is evaluated. The chapter analyzes the results in detail, drawing conclusions on the accuracy, precision and reliability of the method for its intended purpose.
Schlüsselwörter (Keywords)
Enrofloxacin, Differential UV Spectrophotometry, Validation, ICH guidelines, Tablet Analysis, Spectrophotometric method, Fluoroquinolone, Antibacterial agent, Limit of Detection (LOD), Limit of Quantitation (LOQ), Accuracy, Precision.
Frequently Asked Questions: A Comprehensive Language Preview
What is the main objective of this work?
The primary objective is to develop and validate a simple, precise, and accurate spectrophotometric method for determining Enrofloxacin in both bulk and tablet forms. This method aims to adhere to ICH guidelines.
What method is used to determine Enrofloxacin levels?
A differential UV spectrophotometric method is developed and validated. This method utilizes the difference in absorbance of Enrofloxacin at specific wavelengths in acidic and basic solutions.
What are the key themes explored in this work?
Key themes include the development of a novel differential UV spectrophotometric method, its validation according to ICH guidelines, its application to tablet formulations, comparison with existing methods, and assessment of its precision, accuracy, limit of detection (LOD), and limit of quantitation (LOQ).
What are the key aspects of the method validation?
The method validation encompasses linearity, accuracy, precision (intra- and inter-day), LOD, and LOQ, all performed according to ICH guidelines.
What are the chapter summaries?
The Abstract summarizes the development and validation of the spectrophotometric method. The Introduction introduces Enrofloxacin and existing analytical methods, justifying the need for the novel method. Materials and Methods details the materials, equipment, and procedures used. Results and Discussion presents and interprets the findings from method validation and application to tablet formulations.
What are the key materials and equipment used?
The materials and equipment include a spectrophotometer, balance, and ultrasonic cleaner. Specific details on reagents and solutions used in the preparation of standards and samples are provided in the "Materials and Methods" section.
What are the results of the method validation?
Specific values for linearity, precision (%RSD), LOD, and LOQ are provided and discussed in the "Results and Discussion" section. The results demonstrate the accuracy, precision, and reliability of the developed method.
What are the advantages of the differential UV spectrophotometric method?
The differential approach, using the absorbance difference between acidic and basic solutions, enhances the accuracy and precision of Enrofloxacin determination compared to other methods.
How does this method compare to existing methods for Enrofloxacin determination?
The study compares the developed method with pre-existing methods such as RP-HPLC, HPLC, RP-LC, and LC, highlighting the advantages of the proposed differential UV spectrophotometry technique in terms of simplicity and cost-effectiveness.
What are the keywords associated with this work?
Keywords include Enrofloxacin, Differential UV Spectrophotometry, Validation, ICH guidelines, Tablet Analysis, Spectrophotometric method, Fluoroquinolone, Antibacterial agent, Limit of Detection (LOD), Limit of Quantitation (LOQ), Accuracy, and Precision.
- Citar trabajo
- M. Patel (Autor), 2019, Development and Validation of Differential Spectrophotometric Method for Assay of Enrofloxacin in Bulk and Tablet Formulation, Múnich, GRIN Verlag, https://www.grin.com/document/1430140
