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Quality Evaluation Of Different Brands Of Ceftriaxone

By: Sana Tariq | Prof. Dr. Muhammad Ashraf.
Contributor(s): Dr. Muhammad Adil Rasheed | Miss Huma.
Material type: materialTypeLabelBookPublisher: 2012Subject(s): Department of Pharmaoclogy & ToxicologyDDC classification: 1462,T Dissertation note: This study was designed to determine the physicochemical equivalence of selected brands of ceftriaxone sodium registered with the ministry of health government of Islamic republic of Pakistan. Out of 9 selected brands 3 were of lowest price distribution class, 3 from the intermediate price distribution class and remaining three from the highest price distribution class. For quality evaluation 3 parameters were selected which were physical, chemical and microbial. Physical characters analyzed were general appearance, pH, solubility and moisture content. Characters which determine the chemical equivalence were assay of active ingredient and percentage of impurities present in powdered drug. Both these parameters were quantified chromatographically using high pressure liquid chromatography. Clinical efficacy of selected brands of this valuable antibiotic was accessed by determining the minimal inhibitory concentrations against Staphylococcus aureus, Salmonella typhi, Klebsiella pneumonia and Escherichia coli. Statistically all brands were significantly different from one another but all the parameters taken as quality indicators showed results within the range specified by united state pharmacopoeia. None of selected brands of ceftriaxone sodium were found to be counterfeit or even substandard. Irrespective of difference in price, no visible variation was found among different quality assessment parameters, all samples showed compliance with the international pharmacopoeial standards. Through this study it can be concluded that the quality of ceftriaxone in Pakistan is well regulated, all the registered brands are up to the mark and irrespective of variation in price there is no variation in the quality of brands.
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Veterinary Science 1462,T (Browse shelf) Available 1462,T
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This study was designed to determine the physicochemical equivalence of selected brands of ceftriaxone sodium registered with the ministry of health government of Islamic republic of Pakistan. Out of 9 selected brands 3 were of lowest price distribution class, 3 from the intermediate price distribution class and remaining three from the highest price distribution class. For quality evaluation 3 parameters were selected which were physical, chemical and microbial. Physical characters analyzed were general appearance, pH, solubility and moisture content. Characters which determine the chemical equivalence were assay of active ingredient and percentage of impurities present in powdered drug. Both these parameters were quantified chromatographically using high pressure liquid chromatography. Clinical efficacy of selected brands of this valuable antibiotic was accessed by determining the minimal inhibitory concentrations against Staphylococcus aureus, Salmonella typhi, Klebsiella pneumonia and Escherichia coli.
Statistically all brands were significantly different from one another but all the parameters taken as quality indicators showed results within the range specified by united state pharmacopoeia.
None of selected brands of ceftriaxone sodium were found to be counterfeit or even substandard. Irrespective of difference in price, no visible variation was found among different quality assessment parameters, all samples showed compliance with the international pharmacopoeial standards. Through this study it can be concluded that the quality of ceftriaxone in Pakistan is well regulated, all the registered brands are up to the mark and irrespective of variation in price there is no variation in the quality of brands.

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