A SIMPLE, QUICK, REPRODUCIBLE AND LOW-COST HIGH PERFORMANCE LIQUID CHRO1MATOGRAPHIC METHOD FOR THE ANALYSIS OF METRONIDAZOLE IN TABLETSAbstract
A simple, rapid, reproducible and low cost High Performance Liquid Chromatography (HPLC) method was developed and used to assess the quality of some brands of metronidazole tablets being marketed in Abuja, Nigeria. Parameters such as assay for the content of active ingredient, dissolution, disintegration, hardness, friability, and microbial load were evaluated using the methods described in the British Pharmacopoeia. Our results show that, a good linear relationship between Peak Area Response and Concentration in the range of 1.5–50μg/mL and a regression coefficient value of 999 was obtained. The method was found to be very sensitive with values of 25.0 and 15.6ng/mL obtained as Limits of Quantification (LOQ) and Detection (LOD) respectively. The result also showed that all but one (T5) of the eight brands evaluated met the British Pharmacopeia (BP) specifications for weight uniformity test, disintegration test and dissolution test. The brand T5, which failed the weight variation test, equally failed the dissolution test. This product was found to have released more than 110 % of the drug content within 45 minutes against the specification in the pharmacopoeia. This product therefore does not comply with the BP dissolution tolerance limits. However, all the brands examined pass the assay for content of active ingredient.
K. B. Mustapha, C. Y. Isimi , R. A. Kirim , M. I. Aboh , E. T. Wojuola , P. O. Oladosu and M. O. Emeje
Department of Medicinal Chemistry and Quality Control 1, National Institute for Pharmaceutical Research and Development, Idu- Abuja
04 February, 2016
23 March, 2016
01 April, 2016
01 July 2016