Abstract

SIMULTANEOUS DETERMINATION OF BERBERINE AND CURCUMIN IN A TOPICAL GEL USING A VALIDATED HPLC METHOD

Nguyen Ba Trung*, Hoang Ngoc Anh Nhan, Tran Phan Hoang Tuan,

Abstract

A simple, rapid, and reliable HPLC method was developed and validated for the simultaneous quantification of berberine and curcumin in a laboratory-formulated gel. Chromatographic separation was achieved using an Agilent 1260 Infinity II HPLC system equipped with an EC-C18 column (100 mm × 4.6 mm, 4 µm), and a mobile phase consisting of acetonitrile and 0.1% phosphoric acid (85:15, v/v). The method showed excellent linearity (R² > 0.999), high sensitivity, and fulfilled all validation criteria in accordance with ICH guidelines. The limits of detection (LOD) and quantification (LOQ) were 0.06/0.20 µg/mL for berberine and 0.004/0.015 µg/mL for curcumin, respectively. Recovery ranged from 100.65% to 101.37% for berberine and from 99.65% to 100.02% for curcumin, with %RSD values below 1.0% for both repeatability and intermediate precision. This validated method is suitable for routine quality control of gel formulations and offers a robust analytical approach for further pharmaceutical development involving berberine and curcumin.

Keywords: Berberine, Curcumin, HPLC, Method validation, Gel formulation, Simultaneous quantification.