Stability Studies on Flucloxacillin Sodium
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Date
2006
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Abstract
Concerns about the stability of some dosage forms of Flucloxacillin Sodium on the Ghanaian market prompted a scientific study into the stability characteristics of the drug. Blister pack quality, disintegration, iodine-absorbing substances and percentage content of active ingredient were determined for eight (8) different batches of the 10 x 250 mg capsules, and then repeated after six (6) months. Both Iodometric and UV-Spectrophotometric methods of assay were employed. The Percentage content and Iodine-absorbing substances of nine (9) different batches of the oral suspension were monitored at 0, 2, 5 and 7 day intervals uader real-time conditions. The effects of pH of buffer, buffer capacity and sugar (sucrose) on the kinetics of the decomposition of the drug product were also observed using reconstituted Flucloxacillin Sodium BPCRS suspension. A high level of instability was observed in the various batches studied, especially in the capsules, which showed significantly low content of active ingredients and high levels of impurities as iodine-absorbing substances. pH of buffer and buffer capacity were observed to influence the kinetics of the decomposition of the drug product significantly, with pH 5.5 - 6.0 and buffer capacity of 0-0601 observed to be optimum for high stability. Addition of sugar (sucrose) to the formulation caused a decrease in the stability of the reconstituted drug product. Using the Paired t-test, no significant difference was observed between the results obtained from the Iodometric and UV- Spectrophotometric methods.
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A Thesis submitted to the Department of Pharmaceutical Chemistry, Kwame Nkrumah University of Science and Technology, Kumasi in partial fulfillment of the requirements for the degree of Master of Science, 2006