Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. The primary objective of this study was to implement QbD approach to develop and validate a HPLC method that could separate gatifloxacin in the bulk and formulated forms with in-depth understanding of the method and build in the quality during the method development to ensure optimum method performance and its application to study in vitro interaction of gatifloxacin with cations like Calcium, Aluminum and Iron. The method was developed using princetonspher-100 CN Column (150 cm x 4.6 mm i.d., 5m) column with mobile phase consisting of a mixture of phosphate buffer of pH 2.5 and acetonitrile (85:15%v/v). The method fulfilled validation criteria and was shown to be sensitive, with limits of detection (LOD) and quantitation (LOQ) of 0.015 and 0.046 μg/mL, respectively. The calibration graph was linear in the range of 10–50 μg/mL. In vitro interaction study shown that Calcium Sandoz-250 and Calcium Sandoz woman (525 mg of calcium carbonate) decreases dissolution of gatifloxacin tablet by 7.78% and 28.73%, respectively. Iron supplement (Autrin) and aluminum + magnesium containing product decreases dissolution of gatifloxacin tablet by 14.91% and 14.91%, respectively. The method was sound as per ICH guidelines and it can be applied for interactions of cations with gatifloxacin.
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