DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF SALMETEROL XINAFOATEAbstract
Simple, rapid validated stability-indicating HPLC method for estimation of Salmeterol xinafoate was successfully developed. The separation was achieved by using a mobile phase of buffer: methanol in the ratio of 60:40 v/v using HiQ SiL C18 column (150 × 4.6 mm i.d. 5 μm) at 1.2 mL/min as flow rate. The detection was carried out at 252 nm using a PDA detector. The retention time observed was 11.89 ± 0.3 min. This drug was subjected to stress conditions as per ICH Q1A (R2). Linearity was found to be in the concentration range of 10-50 μg/mL with r2 = 0.9958. The suitability of this HPLC method for quantitative estimation of Salmeterol xinafoate was proved by validation by the requirements of ICH guidelines Q2A (R1).
M. Damle * and S. Choudhari
Department of Quality Assurance, All India Shri Shivaji Memorial Society’s College of Pharmacy, Pune, Maharashtra, India.
14 July 2018
26 October 2018
29 October 2018
01 April 2019