Gentamicin is one of the commonly used antibiotics in small animal practice in Nigeria. Fake and substandard drugs are responsible for high cost in both economic terms and lives lost. For decades, Nigeria has been flo...Gentamicin is one of the commonly used antibiotics in small animal practice in Nigeria. Fake and substandard drugs are responsible for high cost in both economic terms and lives lost. For decades, Nigeria has been flooded by counterfeit and poor-quality medicines. Because of the variations in gentamicin C components in different formulations and the effect of this on its efficacy and toxicity, this study was designed to evaluate the percentage of each of the major components of gentamicin C in some injectable gentamicin sulphate generics commonly used in small animal practice in Nigeria. Of the 22 multisource generics of injectable gentamicin sulphate samples analyzed for percentage content of gentamicin C major components using USP HPLC （United States Pharmacopoeia high performance liquid chromatography） method, 95.5% （21 ） met the USP specification. This suggests that there is a significant improvement in the monitoring of quality of drugs marketed in Nigeria, including gentamicin sulphate. Nevertheless, considering the propensity of the manufacturers adjusting their manufacturing processes following product＇s registration by the regulatory body, there is still the need for regular surveillance of drug products by batches to ensure their efficacy and safety.展开更多
文摘Gentamicin is one of the commonly used antibiotics in small animal practice in Nigeria. Fake and substandard drugs are responsible for high cost in both economic terms and lives lost. For decades, Nigeria has been flooded by counterfeit and poor-quality medicines. Because of the variations in gentamicin C components in different formulations and the effect of this on its efficacy and toxicity, this study was designed to evaluate the percentage of each of the major components of gentamicin C in some injectable gentamicin sulphate generics commonly used in small animal practice in Nigeria. Of the 22 multisource generics of injectable gentamicin sulphate samples analyzed for percentage content of gentamicin C major components using USP HPLC （United States Pharmacopoeia high performance liquid chromatography） method, 95.5% （21 ） met the USP specification. This suggests that there is a significant improvement in the monitoring of quality of drugs marketed in Nigeria, including gentamicin sulphate. Nevertheless, considering the propensity of the manufacturers adjusting their manufacturing processes following product＇s registration by the regulatory body, there is still the need for regular surveillance of drug products by batches to ensure their efficacy and safety.
