A simple, rapid, accurate and sensitive method was developed and validated for quantitative analysis of berberine hydrochloride in bulk and nanoemulsion using a reversed-phase high performance liquid chromatography (RP-HPLC). The separation was achieved on stainless steel Purospher® STAR Hibar® C18 analytical column (250 mm × 4.6 mm i.e., 5.0 μm) using acetonitrile : methanol in a ratio of 50:50 % v/v as mobile phase and at a flow rate of 1.0 ml/min. Detection was carried out using a UV detector at 349 nm. The method was validated for accuracy, precision, linearity, LOD, LOQ and robustness. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 20-120 μg/ml with R2 0.998. The limit of detection (LOD) and limit of quantitation (LOQ) obtained for berberine hydrochloride were 1.177677 μg/ml and 3.568719 μg/ml, respectively. The presence of components of the microemulsion did not interfere in the results of the analysis. This method can be used as more convenient and efficient option for the analysis of berberine hydrochloride to establish the quality of the drug substance during routine analysis with consistent and reproducible results.
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