UV method for simultaneous estimation of levofloxacin and ornidazole.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and validation of uv spectrophotometric method for the simultaneous estimation of levofloxacin hemihydrate and ornidazole in combined dosage form by absorbance ratio method
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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Shweta B. Pednekar and Sachi S. Kudchadkar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and validation of uv spectrophotometric method for the simultaneous estimation of levofloxacin hemihydrate and ornidazole in combined dosage form by absorbance ratio method
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Levofloxacin Hemihydrate (levo) and Ornidazole (orni), both important pharmaceuticals, were the focus of a study aimed at developing a new UV spectrophotometric method for their simultaneous estimation. Levofloxacin is a fluoroquinolone antibiotic effective against various bacterial infections, while Ornidazole is a nitroimidazole with activity against protozoa and anaerobic bacteria. The study describes an absorbance ratio method validated for accuracy and precision in estimating these drugs in both pure and pharmaceutical dosage forms.
Development of the UV Spectrophotometric Method
The UV spectrophotometric method developed in the study utilizes the absorbance ratio technique to achieve simultaneous quantification of levo and orni. It identifies the λ max (wavelength of maximum absorbance) for levo at 288 nm and for orni at 317 nm, with an isosbestic point at 305 nm. The method demonstrated linearity with correlation coefficients of 0.9981 for levo and 0.9969 for orni, indicating reliable predictive power across the specific concentration ranges studied (1-11 μg/ml for levo and 2-22 μg/ml for orni).
Validation of the Method
The method underwent extensive validation in accordance with ICH guidelines Q2 (R1). Precision studies revealed that both inter-day and intra-day variations were less than 2% (% RSD), confirming the method's reliability. Recovery studies indicated mean values for levo ranging from 98.47% to 101.43% and for orni from 98.94% to 101.85%, affirming the method's accuracy. The stability of solutions was also assessed, showing no significant changes over three hours at room temperature, which indicates the method's applicability in routine analysis.
Application to Pharmaceutical Formulations
The proposed UV spectrophotometric method allows for the easy and efficient estimation of levo and orni in pharmaceutical dosage forms. A sample solution was prepared from a commercially available tablet formulation containing both drugs, and the method accurately quantified the concentrations of each. The findings show the potential for employing this method for quality control and regulatory purposes in pharmaceuticals, ensuring proper dosage and efficacy in treatment protocols.
Conclusion
The study successfully developed and validated a UV spectrophotometric absorbance ratio method for the simultaneous estimation of Levofloxacin Hemihydrate and Ornidazole. This method is characterized by its simplicity, sensitivity, precision, and accuracy, making it a valuable tool for laboratory analyses and pharmaceutical applications. The research provides a strong foundation for future studies and practical applications in ensuring the effective use of combination therapies in bacterial and protozoal infections.
FAQ section (important questions/answers):
What is the purpose of the UV spectrophotometric method developed?
The UV spectrophotometric method aims to simultaneously estimate Levofloxacin Hemihydrate and Ornidazole in pharmaceutical dosage forms using absorbance ratios for efficient analysis.
What are the key wavelengths used in this study?
Levofloxacin shows a maximum absorbance at 288 nm, while Ornidazole is at 317 nm. An isosbestic point at 305 nm was identified, aiding in their simultaneous estimation.
How reliable is the developed method in terms of precision?
The method demonstrated precision with inter-day and intra-day % RSD values below 2%, satisfying ICH guidelines, indicating consistent results across multiple tests and time periods.
What are the limits of detection for both drugs?
The method established linearity ranges of 1-11 μg/ml for Levofloxacin and 2-22 μg/ml for Ornidazole, ensuring reliable detection within these specified concentrations.
How was the stability of the drug solutions tested?
The stability of the drug solutions, containing 8 µg/ml of Ornidazole and 4 µg/ml of Levofloxacin, was assessed over three hours, with minimal fluctuations in absorbance.
What organizations recognized the validity of the developed method?
The validation of the method followed ICH guidelines, particularly Q2(R1), confirming its suitability through rigorous assessments of linearity, precision, accuracy, and recovery.
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