UV-Spectrophotometric Method Development and Validation of Berberine Hydrochloride

To develop and optimize UV- Spectrophotometric method for Berberine Hydrochloride API. To validate newly developed UV- Spectrophotometric method using various parameter according to ICH guidelines. Materials and method: UV-Spectrophotometric method was developed using Phosphate Buffer pH 7.4 the developed method was standardized in terms of validation parameter such as simple, sensitive, precise, linear, accurate, robust, reproducible as per ICH Q2 (R1) guidelines for estimation of Berberine Hydrochloride in marketed formulation this newly developed method was successfully applied. Results: Berberine Hydrochloride exhibits λ max at 275nm and in the concentration range 50 to 250 μg/ml beers law was obeyed. The Limit of Detection was found to be 42.83 μg/ml and Limit of quantification was found to be 142.79 μg/ml. Recovery of Berbeshine in Marketed formulation was obtained in range of 102-115%, All the precision and repeatability results were observed within the acceptance range i.e. less than 2%. Assay of Berbeshine was found to be in range of 95-97%. Conclusion: The method was found to be simple accurate and precise reproducible and marketed formulation of Berberine Hydrochloride was estimated.