title: Development and validation of a stability-indicating LC method for the assay of lodenafil carbonate in tablets.
abstract: A stability-indicating liquid chromatographic method has been developed for the quantitative determination of lodenafil carbonate in tablets. The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 μm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1% pH 4.0 (65:35, v/v) and UV detection at 290 nm, using a photodiode array detector. A linear response (r = 0.9999) was observed in the range of 10-80 μg/mL. The method showed good recoveries (average 100.3%) and also intra and inter-day precision (RSD < 2.0%). Validation parameters as specificity and robustness were also determined. Specificity analysis showed that no impurities or degradation products were co-eluting with the lodenafil carbonate peak. The method was found to be stability-indicating and due to its simplicity and accuracy can be applied for routine quality control analysis of lodenafil carbonate in tablets.
authors.affiliation: Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. 90610-000, Porto Alegre-RS, Brasil.
authors.forename: Cristiane Franco
authors.initials: CF
authors.lastname: Codevilla
authors.forename: Alice Machado
authors.initials: AM
authors.lastname: Lemos
authors.forename: Leila Schreiner
authors.initials: LS
authors.lastname: Delgado
authors.forename: Clarice Madalena Bueno
authors.initials: CM
authors.lastname: Rolim
authors.forename: Andréa Inês Horn
authors.initials: AI
authors.lastname: Adams
authors.forename: Ana Maria
authors.initials: AM
authors.lastname: Bergold
mesh_terms: D002254:Carbonates / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D010879:Piperazines / Q000737:chemistry*; D011743:Pyrimidines / Q000737:chemistry*; D013607:Tablets / Q000737:chemistry
chemical_list: D002254:Carbonates; D010879:Piperazines; D011743:Pyrimidines; D013607:Tablets; C532120:lodenafil carbonate