Ulu Sevgi Tatar
Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Istanbul 34452, Turkey.
Spectrochim Acta A Mol Biomol Spectrosc. 2007 Jul;67(3-4):778-83. doi: 10.1016/j.saa.2006.08.032. Epub 2006 Sep 5.
A simple, rapid, accurate, precise and sensitive colorimetric method for the determination of finasteride in tablets is described. The proposed methods are based on the formation of ion-pair complexes between the examined drug with bromophenol blue (BPB), bromocresol green (BCG) and bromothymol blue (BTB), which can be measured at the optimum lambda(max). Beer's law is obeyed in the concentration ranges 3.0-15.0, 3.0-15.0 and 5.0-20 microg/mL with BPB, BCG and BTB, respectively. The detection limits of FIN was found to be 1.16 microg/mL for BPB, 1.17 for BCG, 1.76 microg/mL for BTB. All the methods gave similar results and were validated for selectivity, linearity, precision and sensitivity. The proposed methods were directly and easily applied to the pharmaceutical preparation with accuracy, resulting from recovery experiments between 100.11 and 100.33% for BPB, 100.17 and 100.67% for BCG and 100.33 and 100.60% for BTB methods. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The proposed methods have been applied to the determination of drug in commercial tablets. Results obtained from the analysis of commercial preparations with the proposed methods are in good agreement with those obtained with the official HPLC method.
本文描述了一种用于测定片剂中非那雄胺的简单、快速、准确、精密且灵敏的比色法。所提出的方法基于被测药物与溴酚蓝(BPB)、溴甲酚绿(BCG)和溴百里酚蓝(BTB)之间形成离子对络合物,可在最佳最大吸收波长(λmax)处进行测定。分别在BPB、BCG和BTB的浓度范围为3.0 - 15.0、3.0 - 15.0和5.0 - 20 μg/mL时符合比尔定律。发现BPB测定非那雄胺的检测限为1.16 μg/mL,BCG为1.17 μg/mL,BTB为1.76 μg/mL。所有方法均给出相似结果,并针对选择性、线性、精密度和灵敏度进行了验证。所提出的方法直接且易于准确应用于药物制剂,BPB方法的回收率实验结果为100.11%至100.33%,BCG方法为100.17%至100.67%,BTB方法为100.33%至100.60%。低相对标准偏差值表明所提出方法具有良好的精密度,高回收率值表明其准确性。所提出的方法已应用于市售片剂中药物的测定。用所提出的方法对市售制剂进行分析得到的结果与官方高效液相色谱法得到的结果高度一致。