Validation of a chiral HPLC assay for (R)-salbutamol sulfate.

A fast, reliable and specific method for the screening, confirmation, determination and quantitation of salbutamol enantiomers was developed and validated. The described procedure includes a single robust chiral HPLC determination employing a Teicoplanin stationary phase. The method was evaluated for specificity, robustness, linearity, precision and accuracy. Under the chromatographic conditions of the method, known impurities were separated from the active principle.