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.
Table of Contents
1. INTRODUCTION
2. MATERIALS AND METHODS
3. RESULTS AND DISCUSSION
Research Objectives and Key Topics
This study aims to develop and validate a novel, simple, and accurate differential spectrophotometric method for the quantitative estimation of Enrofloxacin in bulk drug form and pharmaceutical tablet formulations, ensuring adherence to international regulatory standards.
- Development of a differential UV spectrophotometric analytical method
- Validation of the proposed method according to ICH guidelines
- Assessment of linearity, precision, and accuracy for Enrofloxacin
- Application of the method to commercial tablet formulations (Baytril)
- Determination of Limit of Detection (LOD) and Limit of Quantitation (LOQ)
Excerpt from the Book
INTRODUCTION
Enrofloxacin or [1-cyclopropyl-6-fluoro-7-(4-ethyl-1-piperazinyl)-1,4-dihydro-4-oxo-3 quinoline carboxylic acid][1]. The chemical structure of the drug is given in (fig. 1). 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[2, 3], HPLC[4-6], RP-LC[7], LC[8] and dissolution study[9] have been reported. Many pharmaceutical products have been assayed by this method[10-13]. But Differential UV spectrophotometric[14] 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.
Summary of Chapters
INTRODUCTION: Provides an overview of Enrofloxacin as a synthetic antibacterial agent and discusses the rationale for developing a novel differential UV spectrophotometric method compared to existing chromatographic techniques.
MATERIALS AND METHODS: Details the instrumental setup, reagents used, the preparation of standard stock solutions, the construction of the calibration curve, and the procedures for tablet assay and method validation.
RESULTS AND DISCUSSION: Presents the findings regarding the spectrophotometric analysis, validation parameters like linearity and precision, and the successful application of the method to commercial tablets with high recovery rates.
Keywords
Enrofloxacin, Differential UV Spectrophotometry, Validation, ICH, Tablet Analysis, Spectrophotometric Method, Analytical Chemistry, Quality Assurance, Pharmaceutical Formulation, UV-Visible Spectroscopy, Recovery Studies, Calibration Curve.
Frequently Asked Questions
What is the core focus of this research paper?
The research focuses on the development and validation of a new differential spectrophotometric method for measuring the concentration of the antibiotic Enrofloxacin in both bulk and tablet forms.
What are the primary thematic fields covered?
The paper covers pharmaceutical analysis, UV-Visible spectroscopy, method validation protocols (ICH guidelines), and quality control of drug formulations.
What is the main objective of the study?
The primary goal is to create a more accessible and accurate analytical alternative to complex chromatographic methods for the routine estimation of Enrofloxacin.
Which scientific method is utilized in this study?
The study employs differential UV spectrophotometry, recording the difference spectrum of the drug in acidic and basic media to derive the amplitude for quantification.
What topics are discussed in the main body?
The main body details the experimental methodology, the specific chemical preparations, instrument parameters, and the comprehensive validation statistics required to prove the method's reliability.
Which keywords best characterize this work?
Key terms include Enrofloxacin, Differential UV Spectrophotometry, Validation, ICH, and Tablet Analysis.
Why was this specific method chosen over common HPLC techniques?
The authors aimed to develop a "novel, simple, and accurate" method, suggesting a need for more cost-effective and straightforward analytical procedures than the standard RP-HPLC methods reported in the literature.
How was the accuracy of the proposed method verified?
Accuracy was verified through recovery studies conducted at 50%, 100%, and 150% of the test concentration, resulting in an average recovery range between 98.36% and 102.3%.
- Arbeit zitieren
- M. Patel (Autor:in), 2019, Development and Validation of Differential Spectrophotometric Method for Assay of Enrofloxacin in Bulk and Tablet Formulation, München, GRIN Verlag, https://www.grin.com/document/1430140
