Method Development and Validation of Salmeterol xinofoate by HPLC

A rapid and precise high performance liquid chromatography method has been developed for the validation of Salmeterol xinofoate in its pure dosage form. The separation was carried out on Agilent Zorbax Bonus RP-(250mm ×4.6mm 5µ) column with a mobile phase consisting of 0.1% Formic acid: Acetonitrile in the ratio of 64:36 v/v as a mobile phase and flow rate is 1ml/min. The detection was carried out at wavelength 234nm. The column thermostatically controlled at 30℃. The retention time of Salmeterol was found to be 1.96 min. The Salmeterol xinofoate followed linearity in the concentration range of 40-60µg/mL with r 2 = 0.999. The developed method was validated for sensitivity, accuracy and precision. The sample was scanned from 200-400nm with PDA detector. The % recovery of sample was found to be. The LOD and LOQ of the Salmeterol xinofoate was found to be 2.67µg/ml and 8.08µg/ml respectively. The suitability of this HPLC method for quantitative estimation of Salmeterol xinofoate was proved by validation by the requirements of ICH guidelines.