Quality and In Vitro Pharmaceutical Equivalence of Ciprofloxacin Tablets Brands in Kenya

The quality and in vitro pharmaceutical equivalence of nineteen generic products of ciprofloxacin tablets with marketing authorization in Kenya are reported. The tablets were assessed for compliance with pharmacopoeial specifications for identity, uniformity of weight, disintegration, drug content and dissolution. All the evaluated generic brands complied with the compendial specifications for identity, uniformity of weight, disintegration and drug content. However, five (26.3%) of the evaluated generic brands were non-compliant in the dissolution test at pH 1.2. In vitro pharmaceutical equivalence analysis showed that ten (52.6%) generic ciprofloxacin tablets brands exhibited similar dissolution profiles as the innovator Cipro® brand at pH 1.2 and pH 4.5, while the other nine (47.4%) had significantly variable dissolution profiles. Therefore only 10 of the 19 generic ciprofloxacin tablets brands evaluated in this study may be regarded as pharmaceutically equivalent to the innovator Cipro® brand.Key words: Ciprofloxacin tablets, quality parameters, pharmaceutical equivalenc

Quantification of three macrolide antibiotics in pharmaceutical lots by HPLC: Development, validation and application to a simultaneous separation

A new validated high performance liquid chromatographic (HPLC) method with rapid analysis time and high efficiency, for the analysis of erythromycin, azithromycin and spiramycin, under isocratic conditions with ODB RP18 as a stationary phase is described. Using an eluent composed of acetonitrile –2-methyl-2-propanol –hydrogenphosphate buffer, pH 6.5, with 1.5% triethylamine (33:7: up to 100, v/v/v), delivered at a flow-rate of 1.0 mL min-1. Ultra Violet (UV) detection is performed at 210 nm. The selectivity is satisfactory enough and no problematic interfering peaks are observed. The procedure is quantitatively characterized and repeatability, linearity, detection and quantification limits are very satisfactory. The method is applied successfully for the assay of the studied drugs in pharmaceutical dosage forms as tablets and powder for oral suspension. Recovery experiments revealed recovery of 97.13–100.28%