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This work employed a quantitative model based on Raman spectroscopy and principal component regression (RS/PCR) to quantify the active ingredient dipyrone (metamizole) in commercially available formulations as an analytical methodology for quality control in the pharmaceutical industry. Raman spectra were collected using a dispersive Raman spectrometer (830 nm, 250 mW excitation, and 20 s exposure time) coupled to a Raman probe. Solutions of dipyrone diluted in water in the range of 80 to 120% of the concentration of commercial formulations (500 mg/mL) were used to develop a calibration model based on PCR to obtain the figures of merit for class I validation from the Brazilian Sanitary Surveillance Agency (ANVISA, RE no. 899/2003). This spectral model was then used to predict the concentration of dipyrone in commercial formulations from distinct brands with 500 mg/mL. A prediction error of 6.5 mg/mL (1.3%) was found for this PCR model using the diluted samples. Commercial formulations had predicted concentrations with a difference below 5.0% compared to the label concentration, indicating the applicability of Raman spectroscopy for quality control in the final product.

Multivariate Method Based on Raman Spectroscopy for Quantification of Dipyrone in Oral Solutions