Experimental design optimization of a sequential injection method for promazine assay in bulk and pharmaceutical formulations.

Abubakr M Idris, Fahad N Assubaie, Salah M Sultan
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引用次数: 17

Abstract

Experimental design optimization approach was utilized to develop a sequential injection analysis (SIA) method for promazine assay in bulk and pharmaceutical formulations. The method was based on the oxidation of promazine by Ce(IV) in sulfuric acidic media resulting in a spectrophotometrically detectable species at 512 nm. A 3(3) full factorial design and response surface methods were applied to optimize experimental conditions potentially controlling the analysis. The optimum conditions obtained were 1.0 x 10(-4) M sulphuric acid, 0.01 M Ce(IV), and 10 muL/s flow rate. Good analytical parameters were obtained including range of linearity 1-150 mug/mL, linearity with correlation coefficient 0.9997, accuracy with mean recovery 98.2%, repeatability with RSD 1.4% (n = 7 consequent injections), intermediate precision with RSD 2.1% (n = 5 runs over a week), limits of detection 0.34 mug/mL, limits of quantification 0.93 mug/mL, and sampling frequency 23 samples/h. The obtained results were realized by the British Pharmacopoeia method and comparable results were obtained. The provided SIA method enjoys the advantages of the technique with respect to rapidity, reagent/sample saving, and safety in solution handling and to the environment.

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原料药和制剂中丙嗪测定顺序注射方法的实验设计优化。
采用实验设计优化方法建立了一种序贯注射分析(SIA)方法,用于原料药和制剂中丙嗪的测定。该方法是基于Ce(IV)在硫酸介质中氧化丙嗪,在512 nm处产生分光光度可检测的物质。采用3(3)全因子设计和响应面法优化可能控制分析的实验条件。得到的最佳工艺条件为1.0 × 10(-4) M硫酸、0.01 M Ce(IV)、10 muL/s流速。获得了良好的分析参数,线性范围为1 ~ 150杯子/mL,线性相关系数为0.9997,平均回收率为98.2%,重复性RSD为1.4% (n = 7次连续注射),中间精密度RSD为2.1% (n = 5周),检出限为0.34杯子/mL,定量限为0.93杯子/mL,进样频率为23个样品/h。所得结果采用英国药典方法实现,结果具有可比性。所提供的SIA方法在快速、试剂/样品节省、溶液处理和环境安全方面具有技术优势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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