AQBD Approach in Chemo metric assisted Method Development for the Estimation of Ciprofloxacin and Metronidazole by UV-VIS Spectrophotometry

Quality by design is applied for the development of various pharmaceutical processes including analytical methods. By applying QbD approach chemometric based analytical method was developed for the estimation of Ciprofloxacin (CFN) and Metronidazole (MND) by UV-VIS spectrophotometry. Solvent Distilled water was utilised and 271.5nm and 319nm were the wavelength of absorbance measurement for CFN and MND respectively. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 1 -14mcg/ml. The accuracy of assay was found 98% for CFN and 100.78% for MND; and the precision study was shown acceptable data as %RSD data varied from 0.6369 to 1.3192 for CFN and from 0.5509 to 1.2171 for MND. The developed method is rigid, robust and efficient for the estimation of CFN and MND from the composition of dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.