Development and Validation of Simple and Precise UV Spectroscopy Method for Quantifying Baicalein & Berberine in Bulk and Formulated Products

Abstract

A simple, precise, and cost-effective UV-visible spectrophotometric method was developed and validated for the simultaneous estimation of baicalein and berberine in bulk and formulations, in accordance with ICH Q2 (R1) guidelines. Calibration standards of baicalein and berberine were prepared, and calibration curves of concentration versus absorbance were plotted. Various analytical method validation parameters such as linearity, accuracy, precision, robustness, ruggedness, limit of detection, and limit of quantitation were calculated. The maximum wavelengths for baicalein and berberine were found to be 274 nm and 344 nm, respectively. The correlation coefficients over the concentration ranges of 0.5-8 μg/ml and 5-30 μg/ml were 0.998 and 0.999 for baicalein and berberine, respectively. The developed UV method demonstrated high precision, accuracy, and sensitivity, with % RSD less than 2. This validated UV-visible method can be efficiently used for the individual and simultaneous estimation of baicalein and berberine in bulk and formulations.