THE QUALITY CONTROL OF AMPICILLIN AND AMPICILLIN/CLOXACILLIN SUSPENSIONS MARKETTED IN KADUNA AND ZARIA

THE QUALITY CONTROL OF AMPICILLIN AND AMPICILLIN/CLOXACILLIN SUSPENSIONS MARKETTED IN KADUNA AND ZARIA

Abstract:

A total of 51 samples of ampici11 in and ampicillin/cloxacillin Oral Preparations from 5 different companies labelled A, B, C, D and E commonly used within Kaduna and Zaria township were assayed using a total of 3 assay methods namely, microbiological, chemical and spectroscopic methods. The level of their ampicillin content in relation to the manufacturers claim was ascertained. Bacillus megatarium NCTC 10342 A76 was found to be suitable for the microbiological assay of ampicillin. Selective determination of ampicillin in its combination with cloxacillin using microbiological assay method was also carried out. Infra-red spectroscopy comfirms the presence of ampicillin in all the samples and the results obtained from the assay demonstrate that the samples had a wide range of amounts of ampicillin. The percentage ampicillin content range from between 57 – 162 using the microbiological, chemical and spetrophotometric assay methods. The products of Company C assayed had ampicillin content less than 80 and 90%. These are lower than the levels recommended by the BP and USP respectively. Samples from one batch of the products from Company B had ampicillin content greater than 120% which is the upper limit recommended by the BP. Products of Companies A, D and E had ampicillin contents within acceptable ranges recommended by both the USP and BP. The non-pharmacopeial methods of Akanni and Ayim (1990) used gave results which correlate with the results obtained from the microbilogical assay for the same products. Results obtained in this work are discussed in the light of the high rate of drug faking, adulteration, manufacture of sub-standard drugs and their implications.

THE QUALITY CONTROL OF AMPICILLIN AND AMPICILLIN/CLOXACILLIN SUSPENSIONS MARKETTED IN KADUNA AND ZARIA