Codevilla Cristiane Franco, Lemos Alice Machado, Delgado Leila Schreiner, Rolim Clarice Madalena Bueno, Adams Andréa Inês Horn, Bergold Ana Maria
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. 90610-000, Porto Alegre-RS, Brasil.
J Chromatogr Sci. 2011 Aug;49(7):502-7. doi: 10.1093/chrsci/49.7.502.
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.
已开发出一种用于定量测定片剂中碳酸洛地那非的稳定性指示液相色谱法。该方法采用Synergi Fusion C18柱（250×4.6 mm，内径，4μm粒径），流动相由甲醇-0.1%pH 4.0乙酸（65:35，v/v）的混合物组成，使用光电二极管阵列检测器在290 nm处进行紫外检测。在10-80μg/mL范围内观察到线性响应（r = 0.9999）。该方法显示出良好的回收率（平均100.3%）以及日内和日间精密度（RSD < 2.0%）。还确定了诸如特异性和稳健性等验证参数。特异性分析表明，没有杂质或降解产物与碳酸洛地那非峰共洗脱。该方法被发现是稳定性指示的，并且由于其简单性和准确性，可用于片剂中碳酸洛地那非的常规质量控制分析。
