Analytical Method Development and Validation for Baclofen and its Stages by High Performance Liquid Chromatography

Objective: To develop and validate a rapid, precise, robust, cost-effective HPLC method for separating Baclofen and its impurities as per the latest regulatory requirement and regulatory expectations. Methods: The successful separation of the drug from its synthetic impurities was achieved byInertsil ODS 3V 150 X 4.6 mm, C18column using a mobile phase system containing 0.1% TFA: Acetonitrile (65: 35 v/v. ) at detector wavelength 225 nm, with flow rate 0.6 ml/min and column temperature 270C. Results: The main Aim of the chromatographic method is to obtain separation of Baclofen from Impurity-A and Impurity-B. Impurities were separated using C18columns as well as different mobile phases. Good linearity was observed for Baclofen over the concentration range of 0.05mg/ml, with the linear regression (Correlation coefficient R = 0.999) and robust. Found the limit of detection and quantification of Baclofenwas 150 ng/ml and 500ng/ml, respectively, for a 10?L injection volume. Baclofen sample solution and mobile phase were stable for at least 48 hours. The % RSD for the assay content in six sample solutions is 0.25. Hence the method for the determination of Baclofen assay is precise. Conclusion: The developed HPLC method was simple, reliable, and cost-effective for Baclofen using the reverse mobile phase and validated as per ICH guidelines. Developed method can be used to quantitatively determine Baclofen in Bulk drug materials in the pharmaceutical industry.