Simultaneous determination of cefixime and erdosteine in combined dosage form using validated spectrophotometric methods.

Abstract

Four accurate and precise spectrophotometric methods were developed and validated for the simultaneous determination of a binary mixture of cefixime (CEF) and erdosteine (ERD) without previous separation. Method A was first derivative ratio spectrophotometric method (1DD) where the amplitudes at 310 and 315nm and the amplitude at 248nm were chosen to simultaneously estimate CEF and ERD, respectively. Method B depends on ratio difference spectrophotometry (RDSM), in which the difference in amplitudes at 325 and 326nm on the ratio spectrum of the mixture was directly proportional to the concentration of CEF; independent of the interfering component. Similarly, the amplitude difference between 236 and 249nm on the ratio spectrum was used for the determination of ERD. Method C was based on simultaneous determination of CEF and ERD using classical least squares (CLS) and partial least squares (PLS) chemometric techniques. Method D was the mean centering of ratio spectra (MCR) at 313 and 237nm for the determination of CEF and ERD respectively. The developed methods were successfully employed to the determination of CEF and ERD in laboratory prepared mixtures and dosage form showing satisfactory recoveries. Methods validation was performed according to the International Conference on Harmonization (ICH) guidelines. The obtained results were statistically compared to those of the reference method, revealing no significant difference with respect to precision and accuracy. Precision and cost effectiveness of the developed methods permit their application in quality control laboratories for the determination of the binary mixture.