Quality Assessment of Some Selected Generic Brands of Lincomycin Capsules Marketed in Gombe Metropolis

Abstract

Lincomycin is an antibiotic indicated for the treatment of serious infections and is reserved for use in cases of penicillin allergy. Several brands of lincomycin capsules are available on the market, resulting in difficulty in determining the best brand that can be interchanged with its more expensive generic. The aim of this study is to determine the best brand of lincomycin that could be substituted with the lincomycin generic. Six brands of lincomycin (500 mg) capsules were randomly selected for this study. Then, physical examination, identification, weight uniformity, disintegration, dissolution, and drug content, amongst other quality control tests, were carried out according to official methods described in the BP 2012 and USP 2012. The result of this study showed that all the brands had NAFDAC registration number and are all within their shelf lives. Their identities were confirmed using FTIR analysis, and all the brands tested have passed the weight uniformity test except brand E and F that failed. The contents of active pharmaceutical ingredients (API) were not exactly the same as labelled in all the brands, except brand A and D, which passed the test by having their percentage drug content of 107.58 and 97.93 %, respectively. All the brands of lincomycin capsule tested had disintegrated within less than 7 minutes, and there was also consistency in drug release as indicated by the dissolution rate ranges of 85.7-93.2 %. In conclusion, all six different brands of lincomycin capsule tested cannot be used interchangeably except for brand A and D, as they have passed all quality controls tests in this study.