Reversed-phase HPLC determination of sildenafil citrate in the presence ofits oxidative-induced degradation products

Citation
Ai. Segall et al., Reversed-phase HPLC determination of sildenafil citrate in the presence ofits oxidative-induced degradation products, J LIQ CHR R, 23(9), 2000, pp. 1377-1386
Citations number
4
Categorie Soggetti
Chemistry & Analysis","Spectroscopy /Instrumentation/Analytical Sciences
Journal title
JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
ISSN journal
10826076 → ACNP
Volume
23
Issue
9
Year of publication
2000
Pages
1377 - 1386
Database
ISI
SICI code
1082-6076(2000)23:9<1377:RHDOSC>2.0.ZU;2-V
Abstract
The determination of sildenafil citrate in the presence of its oxidative-in duced degradation products by reversed-phase HPLC is described. The method was validated as stability-indicating by forced decomposition of sildenafil citrate in acid, base, oxidative, thermal, and photochemical media. The ch romatographic conditions employed a reversed-phase C-18 column (LiChrospher , 5 mu m, 25 cm x 4.6 mm) isocratic elution with 70 mM potassium phosphate monobasic containing 100 mM triethylamine (pH 3.0)-ACN (70:30, v/v) and ult raviolet (UV) detection at 225 nm. The peak area versus sildenafil citrate concentration proved linear over the 10-160% range of the working analytica l concentration of 0.5-mg/mL. Mean absolute recovery of sildenafil citrate using the described method was 100.9 +/- 1.1% (mean +/- SD, n = 9). The pre cision, expressed as relative standard deviation (RSD), of ten replicate in jections of sildenafil citrate reference solution, remained below 0.51%.