文摘
不同stability-indicating奎硫平延胡索酸酯的测定方法
作者(年代):Nesrin K。斋月,Afaf O。穆罕默德,Roaida M。福,Azza A.Moustafa五个准确的,精确的和敏感的方法是测定喹硫平延胡索酸酯(QF)降解产物的存在。方法(一)是基于二阶导数分光光度法2 d,然后在266纳米测量振幅。方法(B)是依赖于测量峰值振幅的一阶导数光谱比1 dd 244, 285和344海里。(C)方法是基于药物的氧化降解产物的分离之后,光密度测量的完整的药物乐队在302海里。丙烯酰胺的分离进行了TLC板硅胶60 F254使用乙酸乙酯/甲醇/ 10%氢氧化铵(8.5:1:0.5卷)作为流动相。方法(D)是高效液相色谱,高效液相色谱分离是通过使用一个Eclipse XDB C18RP-column和甲醇/水的比例80:20 (v / v)作为流动相。流率为1毫升/分钟。方法(E)的反应是基于QF P-Chloranilic酸(PCA)在其降解产物的存在。得到了线性浓度范围1060我g / ml的方法(A)和(B)。而在方法(C)和(D)的情况下,得到了线性浓度范围的4—我g /乐队和1 - 20 g / ml。而在方法(E),实现了线性范围内的40 - 400我g / ml。 In method (A), the mean percentage recovery was 99.9 ± 0.6%. In method (B) the mean percentage recoveries were 99.9 ± 0.4%, 99.2 ± 0.8% and 99.4 ± 0.8% at 244, 285 and 344 m respectively. Method (C) showed percentage mean recovery of 99.9 ± 0.7%, while in methods (D) and (E) were 99.8 ± 0.7% and 99.9 ± 0.4% respectively. The degradation product was obtained in oxidative stress condition, separated, and identified by IR and MS spectral analysis, from which the degradation product was confirmed, and the degradation pathway was suggested. The five methods were found to be specific for QF in presence of different concentration % of its degradation product. The proposed methods were validated according to ICH guidelines Q2 (R1). The five proposed methods were successfully applied for the determination of QF in Seroquel tablets. Statistical comparison between the results obtained by these methods and that obtained by the manufacturer method for the determination of the drug was done, and it was found that there was no significant differences between them.
