萃取分光光度法檢測製劑及人血漿中之 Nimesulide   全文下載

Extractive Spectrophotometric Determination of Anti-Inflammatory Drug Nimesulide in Pharmaceutical Formulations and Human Plasma

本研究目的在開發簡單、快速且靈敏的萃取分光光度法，用於檢測製劑及人血漿中的nimesulide。本方法係基於nimesulide與5種不同試劑：溴甲酚綠（BCG）、溴甲酚紫（BCP）、溴瑞香草酚藍（BTB）、brilliant blue G （BBG）和甲基橙（MO），在pH值2.0 - 3.52的Britton-Robinson緩衝液中反應，會形成有色離子對複合物，這些有色複合物經氯仿萃取後，其吸光值可分別於波長412、410、407、502及482 nm測得。各種分析參數及其效果均已研究，萃取物色彩強且在室溫呈穩定狀態，BCG 、BTB及BBG在濃度範圍2 - 18 μg/mL， BCP在濃度範圍2 - 16 μg/mL，MO在濃度範圍2 - 14 μg/mL時呈線性。全部複合物之化學計量比均為1 : 1，其穩定常數（Kf）亦已算出。本方法成功應用於nimesulide錠劑檢驗，市售產品所添加之賦形劑均不會干擾檢測分析，可應用於品質管控及例行檢驗，因檢驗方法省時、省錢及高鑑別率均極重要。

The goal of the present work is to develop simple, rapid, and sensitive extractive spectrophotometric methods for the assay of nime-sulide in pharmaceutical formulations and human plasma. The methods depend on the formation of colored ion-pair complexes between nimesulide and five different reagents, bromocresol green (BCG), bromocresol purple (BCP), bromothymol blue (BTB), brilliant blue G (BBG) and methyl orange (MO) in Britton-Robinson buffer solutions of pH 2.0 - 3.5. The colored products were extracted in chloroform and absorbance measured at 412, 410, 407, 502 and 482 nm, respectively. The analytical parameters and their effects on the reported systems were investigated. The extracts are intensely colored and very stable at room temperature. The calibration graphs were linear over the concentration range of 2 - 18 µg/mL for BCG, BTB and BBG, 2 - 16 µg/mL for BCP and 2 - 14 µg/mL for MO. The stoichiometry of the reaction was found to be 1 : 1 in all cases and the conditional stability constant (Kf) of the complexes were calculated. The proposed methods were successfully extended to pharmaceutical preparations in tablet form. Excipients used as additives in commercial formula-tions did not interfere with the analysis. The proposed methods can be recommended for quality control and routine analysis where time, cost effectiveness and high specificity of the analytical technique are of great importance.