Development and analytical validation of a multivariate calibration method for determination of amoxicillin in suspension formulations by near infrared spectroscopy

摘要: This paper proposes a new method for determination of amoxicillin in pharmaceutical suspension formulations, based on transflectance near infrared (NIR) measurements and partial least squares (PLS) multivariate calibration. A complete methodology was implemented developing the proposed method, including an experimental design, data preprocessing by using multiple scatter correction (MSC) outlier detection high values leverage, X Y residuals. The best PLS model obtained with seven latent variables range from 40.0 to 65.0 mg mL−1 amoxicillin, providing root mean square error prediction (RMSEP) 1.6 mL−1. validated accordance Brazilian international guidelines, through estimate figures merit, such as linearity, precision, accuracy, robustness, selectivity, analytical sensitivity, limits quantitation, bias. results determinations four commercial formulations were agreement official performance liquid chromatographic (HPLC) at 99% confidence level. pseudo-univariate calibration curve also net analyte signal (NAS). chemometric presented advantages rapidity, simplicity, low cost, no use solvents, compared principal alternative methods HPLC.