Abstract
Objective: The present study focuses on developing two visible spectrophotometric methods for cefixime trihydrate (CFT) by the utilization of analytical quality by design space concept. The critical method variables were screened and optimized by factorial design.
 Methods: In methods A and B, CFT reacts with 3-methyl-2-benzothiazolinone hydrazone hydrochloride in an acidic medium having λmax at 630 nm and CFT reacts with 1, 10 phenanthroline (Phen) showing λmax at 510 nm, respectively. Fractional factorial design was employed for the initial screening of independent variables for both methods. The main, interaction, and quadratic effects of the most significant factors on the preferred response (absorbance) for methods A and B were studied employing central composite design (CCD) with response surface methodology.
 Results: The method was linear (r2=0.9983 and 0.9986 for methods A and B), accurate (mean recovery = 100.06% and 99.26% for methods A and B), precise (relative standard deviation, % relative standard deviation = 0.9214, 1.025 and 0.1919, 0.2136 for methods A and B).
 Conclusion: The outcome of the proposed work has evidently revealed that quality by design concept can be efficiently enforced in the optimization of spectrophotometric technique for the quantification of CFT in pharmaceutical raw materials and formulations by minimum experimental runs.
Highlights
A detailed study on the analytical methods employed for the estimation of Cefixime trihydrate (CFT) includes spectrophotometry [2,3,4,5,6,7,8,9,10,11,12], spectrofluorimetry [7], voltammetry [13], and high-performance liquid chromatography (HPLC) [2,4,14,15] as a single component
Two visible spectrophotometric methods were optimized for the quantification of CFT using methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) and 1, 10 phenanthroline as the derivatizing reagents
The experimental design approach was utilized for screening most significant factors and optimization of those significant factors having an influence on the response by central composite design
Summary
Cefixime trihydrate (CFT) chemically, [(6R, 7R)-7-[2-(2-amino-4thiazolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct2-ene-2-carboxylic acid, 72-(Z)-[O-(carboxy methyl)oxime] trihydrate] (Fig. 1), a third-generation cephalosporin is an oral broad-spectrum antibiotic that is highly active against various bacterial strains such as Enterobacteriaceae, Haemophilus influenzae, and Streptococcus pyogenes [1].A detailed study on the analytical methods employed for the estimation of CFT includes spectrophotometry [2,3,4,5,6,7,8,9,10,11,12], spectrofluorimetry [7], voltammetry [13], and high-performance liquid chromatography (HPLC) [2,4,14,15] as a single component. The reported spectrophotometric methods [11,12] utilize one variable at a time, and the method is ineffective and yields deceitful results, which are to be avoided [25] This necessitates the use of a systematic and mathematical means of optimizing the reaction parameters to acquire crucial and precise results with less number of experiments. A response surface technique requires a minimum number of experiments and is utilized in the current study to optimize, validate, and analyze CFT spectrophotometrically. The proposed method involves screening and optimization of the experimental variables by the concept of fractional factorial design (FFD), central composite design by RSM to develop visible spectrophotometric methods for estimating the content of CFT in pharmaceutical raw materials and formulations. The developed method was validated as per the ICH Q2 (R1) guidelines [30]
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