A comparative study on the prevalence of substandard ampicillin/cloxacillin preparations in the Nigerian market: mid 1990's and present

Abstract

A Comparative evaluation of the quality (content of active pharmaceutical ingredients) of different brands of Ampicillin/Cloxacillin products available in Nigerian market, for the period between mid 1990s and 2004 was carried out. The samples consisted of ten, eight, and four different brands of Ampicillin/Cloxacillin capsules, suspension and injections respectively. All the different brands were analyzed using a slightly modified HPLC, U.S.P. method at a wavelength of 225nm. The absolute drug content of the various brands were calculated and found to range from 66.4 to 118.2% for Cloxacillin and 80.0 to 96.5% for Ampicillin in the capsule formulations. The absolute drug content was found to range from 37 to 173.5% for Cloxacillin and 78.3 to 12 8.7% for Ampicillin in the suspension dosage forms. Also, the percentage content in injection formulation ranged from 80.2 to 118.2% for Cloxacillin and 91.8 to 122.7% for Ampicillin. The prevalence of substandard ampicillin/cloxacillin capsule, suspension, and injection in this study was found to be 40%, 50% and 25% respectively. In comparison, similar study done in our laboratory in the mid 1990's gave the following prevalence of substandard ampicillin/cloxacillin products; 80% capsules, 100% suspension and 40% for injection. The findings in this study indicate that there is almost a 50% drop in the prevalence of substandard ampicillin/cloxacillin preparations in the Nigerian market. The implication of this findings to Nigeria is that the current efforts by the food and drug regulatory authority to wage war against substandard drug is yielding positive results but a lot still needs to be done.