Efficient UPLC and spectrophotometric MC methods for simultaneous determination of cefixime and sodium benzoate in their dosage form and in its degradation product of cefixime-E Isomer. Application of lean six sigma and in-vitro dissolution studies

Abstract

The main objective of this study is to develop and validate a novel RP-UPLC and spectrophotometric mean centering Methods for simultaneous estimation of cefixime and sodium benzoate in their dosage form and in Its Degradation Product of cefixime-E isomer and application of Quality tools and Lean Six Sigma methodologies to construe the data integrity of quality attributes which will give strength, confidence, and precision to control and emphasize that the Process Capability Index (Cpk) is >1.33. Isocratic chromatographic condition was evaluated at ambient temperature using Waters CORTECS® C18 column (50 mm × 4.6 mm, 2.7 μm particle size), with a mobile phase composing of acetonitrile: 0.05M Phosphate Buffer (35:65 v/v) at flow rate of 0.3 mL /minute and UV detection at 230 nm with injection volume of 0.5 μL and total run time of 7 min. The UV method is mean centering of the ratio spectra (MC), which is relied on mean centering of the first ratio spectral data of both drugs in their binary mixture at 225 nm for SDB, while CFX was detected at zero order spectra of 290 nm, as no overlapping from the combined drug has been found. The method was successfully applied to comparative in vitro dissolution studies for cefixime (CFX) in the Generic product; Rivaxime 200 mg Cap and Rivaxime 400 mg Cap therefore, it had been considered equivalent to the innovator product; Suprax 200 mg Cap and Suprax 400 mg Cap using FDA dissolution medium.