Chemometric Assisted UV-Spectrophotometric Quantification of Cefaclor in Suspension Dosage Form

Abstract

In this current study, the quality by design (QbD) concept is used for creating and validating a unique, resilient, accurate, and reliable spectrophotometric approach to quantify cefaclor (CEF) in injections. Fractional factorial design (FFD) was a design implemented to screen the initial parameters. Moreover, the variables went through the central composite design (CCD) to assess the dependency and optimize the design. Several measures were analyzed statistically to determine the appropriateness of the data obtained from the experiments. At 265 nm, by the use of ethanol, cefaclor displays an absorption maximum. Variables like screening, slit-width, and sampling interval were recognized as critical methods and again, evaluation was done by a CCD. A good linearity was produced for cefaclor in the range of 2 to 12 μg/mL, with R2>0.9993. The process was determined for being perfect, having a good average percent recovery (greater than 100%). According to ICH guidelines, validation of the developed method was performed. By implementing QbD principles, the spectrophotometric was created and designed to integrate the quality into the method. The process was manifested for being flexible and appropriate for identifying CEF in pharmaceuticals.