The Quantitative Analysis of Solid Dosage Forms of Itopride using Raman Spectroscopy

This study explores the application of Raman spectroscopy for identifying and quantifying itopride in solid dosage forms with varying concentrations of active ingredients and excipients. Raman spectroscopy provides a non-invasive, rapid, and accurate detection method that is ideal for pharmaceutical analysis.

The Raman spectral features of itopride in solid dosage forms were analyzed using Principal Component Analysis (PCA) and Partial Least Squares Regression Analysis (PLS-RA) as multivariate data analysis techniques.

PCA effectively distinguished Raman spectral data of various itopride drug samples. PLS-RA facilitated quantitative analysis, yielding an R² value of 0.999%, indicating an excellent explanation of model variability. The root mean square error of calibration and prediction were 0.23 mg and 3.02 mg, respectively. Furthermore, PLS-RA accurately determined the active pharmaceutical ingredient concentration in unknown formulations, with a calculated concentration of 79.66/80 mg (w/w) compared to the actual concentration of 80/140 mg (w/w).

These findings demonstrated that the concentration of itopride in pharmaceutical samples using an established Partial Least Squares Regression calibration model can be determined with reliability.