Abstract

Problem statement: Several studies were carried out to develop and validate a simple, rapid and accurate spectrophotometric method for the analysis of tetracycline (TC) and oxytetracycline (OTC) in the pure form and in pharmaceutical dosage forms, despite the varieties of these analytical techniques, the literature revealed that no spectrophotometric method for determination of tetracycline and oxytetracycline using charge transfer complexation with chloranilic acid has been reported. Approach: In the present study, a new and simple spectrophotometric method is described for the determinations of tetracycline (TC) and oxytetracycline (OTC), the method is based on the molecular interaction between the tetracyclines and Chloranilic Acid (CA), to form a charge-transfer complex in which the drugs acts as n-donor and chloranilic acid as I€-acceptor in acetonitrile. The spectra, various experimental parameters for the reaction, the stability of the complex and the validty of the method were investigated. Results: The formed complex was found to absorb maximally at 540nm, Beer’s law is obeyed in the concentration ranges 2.5-30 µg mL-1 and 5.0-40 µg mL-1 for TC and OTC, respectively. The limits of detection (S/N = 3) were 0.40 µg mL-1 for tetracycline and 0.50 µg mL-1 for oxytetracycline. The molar ratio was found to be approximately 1:1, confirming that one molecule of tetracycline or oxytetracycline combines with one molecule of chloranilic acid. Conclusions and Recommendations: The proposed method was found to be rapid, accurate and sensitive and may be applied for estimation of named drugs in pharmaceutical dosage forms without interferences from the common additives encountered. Percentage recoveries ranged from 99.17%±0.95-100.38%±0.82. From the statistical analysis of the obtained results one can conclude that no significant difference between the proposed method and other official methods as evident from the t-test and variance ratio. These findings recommend the utility of the proposed method in the quality control analysis of TC and OTC in the pure form and pharmaceutical dosage forms.

Highlights

  • Tetracyclines possess a wide range of antimicrobial activity against gram-positive and gram-negativeInjection Analysis (FIA)-chemiluminescence’s[15,16] and FIA/amperometric detection[17], in addition to electrochemical methods[18,20].UV-Visible spectrophotometry is still considered to bacteria; they have been used in human be as a convenient and low cost method for the medicine for the treatment of infectious disease and determination of pharmaceuticals in bulk and dosage as an additive in animal feed to promote growth. forms

  • Pharmaceutical grade tetracycline and oxytetracycline were obtained from El-Nasser Chemical Co., Egypt and their standard solutions were prepared as 0.05% w/v in methanol, all solutions containing TC and OTC were protected from direct sunlight and artificial light throughout the analysis, because of the photosensitivity of tetracyclines to light

  • The addition of chloranilic acid to tetracycline having a lone pair of electrons results in the formation of a charge transfer complex of the n-π type

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Summary

Introduction

Tetracyclines possess a wide range of antimicrobial activity against gram-positive and gram-negativeInjection Analysis (FIA)-chemiluminescence’s[15,16] and FIA/amperometric detection[17], in addition to electrochemical methods[18,20].UV-Visible spectrophotometry is still considered to bacteria; they have been used in human be as a convenient and low cost method for the medicine for the treatment of infectious disease and determination of pharmaceuticals in bulk and dosage as an additive in animal feed to promote growth. forms. Several spectrophotometric and colorimetric the development of new antimicrobial agents methods have been reported for the determination of that are more effective for specific infections and less toxic have declined the indications for their use, tetracyclines are still used widely in both human and veterinary medicine[1]. Both the British Pharmacopoeia[2] and the United States Pharmacopoeia[3] recommend the use of HPLC tetracyclines in bulk material and dosage forms based on their reaction with different reagents such as ammonium vanadate[21], cupric chloride[22], Diphenyl-1Picrylhydrazyl (DPH)[23] and sodium molybdate[24].

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