Optimization and Validation of GC Method for Determination of Methanol as Organic Volatile Impurity in Atenolol Bulk Drug

Methanol is used during synthesis of atenolol and therefore present as organic impurity in bulk drug. Gas chromatography with headspace is widely used for the determination of residual solvents in API’s. The presented study is performed to develop and validate gas chromatography method for determination of methanol in atenolol API. The developed method was validated in terms of specificity, linearity, precision, accuracy, limit of detection (LOD) and limit of quantitation (LOQ). The developed method was utilized for the investigation of methanol content in bulk drug. The presented method can be utilized for methanol determination in atenolol in pharmaceutical industries.