Chemometric Assisted UV-Spectrophotometric Quantification of Tigecycline in Parenteral Dosage Form

Abstract

Relating to the current study, the quality by design (QbD) concept is used for creating and validating an unique, resilient, accurate, and reliable spectrophotometric approach to quantify Tigecycline (TIG) 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 250 nm, by the use of ethanol, TIG displays an absorption maximum. Variables like screening, slit-width, and sampling interval were recognized as critical method and again, evaluation was done by a CCD. A good linearity was produced for TIG within a range of 2 to 12 μg/mL, with R2 less than 0.999. The process was determined to be perfect, having a good average percent recovery (greater than 100%). According to ICH guidelines, validation of the developed method was performed. By the implementation of QbD principles, spectrophotometric techniques were created and planned to, integrate the qualities into the methods. These processes were manifested for being flexible and pertinent for identifying TIG in pharmaceutical dose regimens.