Gomes Patricia, Steppe Martin
Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Programa de Pós-Graduaçâo em Ciências Farmacêuticas, Porto Alegre, RS, Brazil.
J AOAC Int. 2006 Sep-Oct;89(5):1296-9.
First-derivative spectrophotometry, applying the peak-zero method, was developed for the determination of rosiglitazone (RSG) in coated tablets. The solutions of standard and sample were prepared in ethanol. Quantitative determination of the drug was performed at 331.4 nm (N = 4; delta lambda = 3.2 nm) and was evaluated for the parameters specificity, linearity, precision, and accuracy. The specificity test showed that there was no interference from excipients commonly found in the commercial pharmaceutical formulation at 331.4 nm. The standard curve showed a correlation coefficient of 0.9997. Precision was demonstrated by a relative standard deviation value of 0.50%. The recovery test resulted in an average of 100.06%, which confirmed the accuracy of the method. The results for first-derivative spectrophotometry (D(1)), liquid chromatography, and micellar electrokinetic chromatography were compared by analysis of variance (ANOVA), and there were no significant differences among these methods. Therefore, D(1) can be easily and directly applied to analyze RSG in coated tablets.
采用峰-零法的一阶导数分光光度法被开发用于测定包衣片中的罗格列酮（RSG）。标准溶液和样品溶液均用乙醇配制。在331.4 nm处（N = 4；Δλ = 3.2 nm）对药物进行定量测定，并对特异性、线性、精密度和准确度等参数进行评估。特异性试验表明，在331.4 nm处，市售药物制剂中常见的辅料无干扰。标准曲线的相关系数为0.9997。精密度通过相对标准偏差值0.50%得以证明。回收率试验的平均值为100.06%，证实了该方法的准确性。通过方差分析（ANOVA）比较了一阶导数分光光度法（D(1)）、液相色谱法和胶束电动色谱法的结果，这些方法之间无显著差异。因此，D(1)可轻松、直接地用于分析包衣片中的RSG。
