1. Development and Validation of a Stability-Indicating LC Method for the Assay of Lodenafil Carbonate in Tablets.
- Author
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Codevilla, Cristiane Franco, Lemos, Alice Machado, Delgado, Leila Schreiner, Rolim, Clarice Madalena Bueno, Adams, Andréa Inês Horn, and Bergold, Ana Maria
- Subjects
LIQUID chromatography ,STABILITY (Mechanics) ,PHOSPHODIESTERASE inhibitors ,DRUG tablets ,DRUG analysis ,PHOTODIODES ,DETECTORS ,MIXTURES - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2011