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

Abstract

Objective: 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. Methods: 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. Results: 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). Conclusion: 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.