1. Development and validation of a stability-indicating LC method for the assay of lodenafil carbonate in tablets.
- Author
-
Codevilla CF, Lemos AM, Delgado LS, Rolim CM, Adams AI, and Bergold AM
- Subjects
- Drug Stability, Tablets chemistry, Carbonates chemistry, Chromatography, High Pressure Liquid methods, Piperazines chemistry, Pyrimidines chemistry
- 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.
- Published
- 2011
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