A high-performance thin-layer chromatographic (HPTLC) method has been developed and validated as per ICH guidelines for simultaneous identification and quantification of the basic and acidic moieties of salmeterol xinafoate salt. Salmeterol xinafoate was split into two spots, salmeterol base and xinafoic acid at RF values 0.48 ± 0.02 and 0.36 ± 0.04, respectively, on pre-coated silica gel 60 F254 HPTLC plates using ethyl acetate-methanol-ammonia solution 33% (8:1.5:0.5 v/v) as a mobile phase. On the fluorescent plate, the spots were located by fluorescence quenching and spectrodensitometric quantification of salmeterol base was carried out at 300 nm and xinafoic acid at 250 nm under reflection-absorption mode. The calibration curves were linear in the range of 1–6 μg per spot for salmeterol base and 0.5–4 μg per spot for xinafoic acid with good correlation coefficients (0.9964, 0.9986), and percentage accuracy of 100.11 ± 0.84 and 99.13 ± 0.86, respectively. The proposed method was found to be reproducible for quantitative analysis of salmeterol xinafoate in drug substance, inhaled pharmaceutical dosage forms and spiked human urine and will serve in quality control analysis. Statistical analysis was performed and validation method has been estimated in terms of linearity range, limits of detection (LOD) and quantification (LOQ), accuracy and precision.
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