Zawilla N H, Mohammad M Abdul Azim, El Kousy N M, El-Moghazy Aly S M
National Organisation of Drug control and Research, Cairo, Egypt.
J Pharm Biomed Anal. 2002 Jan 1;27(1-2):243-51. doi: 10.1016/s0731-7085(01)00518-0.
Three sensitive and reproducible methods for quantitative determination of aceclofenac (AC) in pure form and in pharmaceutical formulation are presented. The first method is based on the reaction between the drug via its secondary aromatic amino group and p-dimethylaminocinnamaldehyde (PDAC) in acidified methanol to give a stable coloured complex after heating at 75 degrees C for 20 min. Absorption measurements were carried out at 665.5 nm. Beer's law is obeyed over concentration range 20-100 microg ml(-1) with mean recovery 100.33 +/- 0.84. The other two methods are high performance liquid chromatography (HPLC) and densitometric methods by which the drug was determined in the presence of its degradation products over concentration range of 20-70 microg ml(-1) and 1-10 microg per spot and mean recoveries are 99.59 +/- 0.90 and 99.45 +/- 1.09, respectively.
本文介绍了三种灵敏且可重复的方法,用于定量测定纯品及药物制剂中的醋氯芬酸(AC)。第一种方法基于药物通过其仲芳氨基与对二甲氨基肉桂醛(PDAC)在酸化甲醇中发生反应,在75℃加热20分钟后生成稳定的有色络合物。在665.5nm处进行吸光度测量。在20 - 100μg ml⁻¹浓度范围内符合比尔定律,平均回收率为100.33 ± 0.84。另外两种方法是高效液相色谱法(HPLC)和光密度法,通过这两种方法可在药物存在降解产物的情况下,在20 - 70μg ml⁻¹浓度范围和每点1 - 10μg浓度范围内测定药物,平均回收率分别为99.59 ± 0.90和99.45 ± 1.09。