RP-HPLC Method Development and Validation of Bambuterol in Formulations

A simple, accurate RP-HPLC method was developed and validated for rapid analysis of
Bambuterol in formulation. Isocratic elution at a flow rate of 1.2ml/min was employed on a symmetry
Chromosil C18 (250x4.6mm, 5μm in particle size) at room temperature. The mobile phase consisted of
Methanol: ACN: TEA 30:67:3 (V/V). The UV detection wavelength was 253 nm and 20μl sample was
injected. The retention time for Bambuterol was 6.2 min. The percentage RSD for precision and accuracy
of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The
method was successfully applied for regular analysis of Bambuterol in tablet dosage form and bulk drug.