Kord A S, Tumanova I, Matier W L
Oculon Corporation, Cambridge, MA 02139, USA.
J Pharm Biomed Anal. 1995 Apr;13(4-5):575-80. doi: 10.1016/0731-7085(95)01254-i.
A novel HPLC method for determination of EDTA in a cataract inhibiting ophthalmic drug product has been developed. In this method EDTA was converted to Cu(II)EDTA complex, using Cu + 2 containing mobile phase, after injection into the chromatographic system. This allowed complexation of EDTA with Cu + 2 without interference from formulation ingredients. The Cu(II)EDTA complex was separated from drug substance, impurities, degradants and other formulation excipients by a 250 x 4.1 mm anion exchange column and detected at UV wavelength 250 nm. The mobile phase consisted of 2 mM cupric nitrate, 11 mM nitric acid, and 25% (v/v) acetonitrile at pH 3.0. This stability indicating assay has been validated and shown to be specific, linear, precise, accurate and rugged for routine EDTA analysis.
已开发出一种用于测定白内障抑制眼科药物产品中EDTA的新型高效液相色谱法。在该方法中，将含有Cu + 2的流动相注入色谱系统后，EDTA被转化为Cu(II)EDTA络合物。这使得EDTA与Cu + 2发生络合，而不受制剂成分的干扰。通过250×4.1 mm阴离子交换柱将Cu(II)EDTA络合物与原料药、杂质、降解产物及其他制剂辅料分离，并在250 nm紫外波长下进行检测。流动相由2 mM硝酸铜、11 mM硝酸和pH值为3.0的25%（v/v）乙腈组成。这种稳定性指示测定法已经过验证，对于常规EDTA分析而言，具有特异性、线性、精密度、准确性和耐用性。
