Quality assessment of veterinary pharmaceuticals: a case of Oxtetracycline and Praziquantel

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Date
MAY, 2016
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Antimicrobial resistance is a global health problem with severe consequences. Efforts aimed at possible reduction must therefore be encouraged. Assurance of the quality of veterinary pharmaceuticals therefore has a direct link with improving disease control in humans. Resistant organisms can develop as a result of poor quality antibiotics. Resistant organisms from animals can be transferred through the food chain to humans. The food-borne route has been reported to be the dominant route in the spread of resistance from non – human sources to humans. Assessment of the quality of veterinary pharmaceuticals containing Oxytetracycline and Praziquantel was studied. Veterinary Pharmaceuticals containing Oxytetracycline (OTC) and Praziquantel (PZQ) were sampled from a manufacturer, veterinary hospitals, farms and open market. In all, twenty- five (25) samples were analysed using RP-HPLC. Sensitive, fast, selective and precise RP-HPLC methods were developed and validated for Oxytetracycline and Praziquantel in their pure forms and in formulated products. Chromatographic conditions developed for Oxytetracycline was mobile phase composition of acetonitrile: water: trifluoroacetic acid (TFA) (85:14.5:0.5(1%v/v); v/v/v) respectively. The stationary phase employed was an Altima Cyano 100A 5µ, (250mm x 4.6mm) column at a wavelength of detection, 254nm. The retention time was 3.326 ± 0.05 minutes. A flow rate of 2ml/min was used. Chromatographic conditions developed for Praziquantel was mobile phase composition of acetonitrile: water: TFA (45:54.95:0.05(1%v/v); v/v/v). The stationary phase employed was ReproSil 100 CN 5µ, (250mm x 4.6mm) and a detection wavelength of 230 nm. The retention time was 6.80 ± 0.07 minutes. All determinations were made at ambient temperatures for Oxytetracycline and Praziquantel. Calibration curves with good coefficient of correlation (r2) values of 0.9994 and 0.9996 were obtained for Oxytetracycline and Praziquantel respectively. Highly sensitive LOD values of 0.01054mg/ml and 0.03156mg/ml were obtained for Oxytetracycline and Praziquantel respectively. LOQ values of 0.03196 mg/ml and 0.09564 mg/ml were obtained for Oxytetracycline and Praziquantel respectively. The analytical method developed was then applied to commercial veterinary products sampled. Fifteen (15) samples were of good quality whereas ten (10) samples were observed to be sub-standard.
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A dissertation submitted to The Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences KNUST, in partial fulfilment of the requirements for the degree of Master of Philosophy in Pharmaceutical Chemistry, 2016
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