Development and validation of a new spectrophotometric method for simultaneous determination of spiramycin and metronidazole in tablet pharmaceutical dosage forms using chemometrics technique in comparison with HPLC

Abstract

A new, easy, fast, and cost-effective simultaneous spectrophotometric method for determining the combined concentration of spiramycin and metronidazole in tablet pharmaceutical formulations was developed and proposed. The suggested method was validated using two chemometric techniques, namely partial least square regression (PLS) and principal component regression (PCR). The significance of the proposed method is that pretreatment or separation steps are not required. Various drug concentrations and instrumental spectra of 25 mixed solutions of spiramycin and metronidazole were used for model design and validation. The UV analysis of the prepared mixtures was recorded with respect to a selected solvent blank in the wavelength range of 200–375 nm. The digitized absorbance was sampled at 0.2 nm intervals. The R2 values of 1 and 0.9998 assigned for the PLS of spiramycin and metronidazole, and those of 0.9991 and 0.9998 for the PCR of spiramycin and metronidazole, respectively, exhibited greater prediction efficiencies. The results were statistically compared to those of the HPLC reference method. The statistical comparison between the recommended (PLS and PCR) and reference HPLC method did not find any appreciable variations in accuracy or precision. The suggested approach is simple, effective, and trustworthy enough to be employed as an alternative analytical method for quality control of drug analysis in the pharmaceutical industry.