DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF SALMETEROL XINAFOATE
AbstractSimple, 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).
Article Information
39
1865-1869
752
1283
English
IJPSR
M. Damle * and S. Choudhari
Department of Quality Assurance, All India Shri Shivaji Memorial Society’s College of Pharmacy, Pune, Maharashtra, India.
mcdamle@rediffmail.com
14 July 2018
26 October 2018
29 October 2018
10.13040/IJPSR.0975-8232.10(4).1865-69
01 April 2019
Download