Development and Validation of UV-Spectrophotometric Methods for the Determination of Berberine in Polymeric Nanoparticles

Abstract

A simple, specific, economic, accurate, and reproducible UV-spectrophotometric methods were developed and validated for the estimation of berberine (BRC) in bulk and pharmaceutical formulation. The λmax of BRC in 0.1 N hydrochloric acid (pH 1.2), phosphate buffer (pH 6.8), and water was found to be 346 nm, 343 nm and 260 nm respectively. Beer's law was obeyed in the concentration range of 5–30 μg/ml (R2 = 0.9698) in water, 5–25 μg/ml (R2 = 0.9991) in 0.1 N HCl buffer (pH 1.2) and 5–35 μg/ml (R2 = 0.9935) in phosphate buffer (pH 6.8). These methods were tested, and validated for various parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD), and limit of quantification (LOQ) according to ICH guidelines. The method showed good reproducibility and recovery with percent relative standard deviation less than 2%. Moreover, the accuracy and precision obtained implied that UV spectroscopy can be a cheap, reliable, and less time consuming alternative for chromatographic analysis. The proposed methods were successfully applied for the determination of BRC in pharmaceutical formulation. The BRC estimated from the formulation was found to be well within limits (±5% of the labelled content of the formulations). The proposed methods are highly sensitive, precise, accurate, and can be employed for the routine analysis of berberine in bulks as well as in the commercial formulations.