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A new method was established for simultaneous estimation of Salmeterol and Fluticasone propionate by RP-HPLC method.
The chromatographic conditions were successfully developed for the separation of Salmeterol and Fluticasone propionate by
using Zodiac sil C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol:
phosphate buffer (KH2PO4and K2HPO4) phosphate pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength
was 240nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention
times were found to be 2.170 mins and 7.280mins. The % purity of Salmeterol and Fluticasone propionate was found to be
99.1% and 98.2% respectively. The system suitability parameters for Salmeterol and Fluticasone propionate such as
theoretical plates and tailing factor were found to be 12294, 1.27 and 10491 and 1.03, the resolution was found to be 8.67.
The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Salmeterol and
Fluticasone propionate was found in concentration range of 16µg-80µg and 25µg-125µg and correlation coefficient (r2) was
found to be 0.999 and 0.998, % recovery was found to be 101.7% and 102.0%, %RSD for repeatability was 0.8and 0.5, %
RSD for intermediate precision was 1.99 and 1.82 respectively. The precision study was precision, robustness and
repeatabilty.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively
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