Camacho M A, Torres A I, Gil M E, Obregón M M, Ruz V
Department of Pharmacy and Pharmaceutical Technology, School of Pharmacy, Complutense University, Madrid, Spain.
Arzneimittelforschung. 1994 May;44(5):659-62.
A high performance liquid chromatography (HPLC) method for the qualitative and quantitative determination of amonafide (CAS 69408-81-7) and mitonafide (CAS 54824-17-8), two new antineoplastic molecules, in finished pharmaceutical dosage forms (tablets) is developed and validated. The results submitted in this work suggest that HPLC method is linear (range 0.54 microgram to 2.70 micrograms for amonafide, and 1.40 micrograms to 5.25 micrograms for mitonafide), sensitive (discriminator capacity 0.1098 microgram for amonafide and 0.1324 microgram for mitonafide), precise (coefficient of variation < or = 2.39% within run, < or = 1.18% between run for tablets with amonafide, and < or = 1.38% within run and < or = 0.96% between run for tablets with mitonafide), accurate (mean recovery 97.55, 98.85, 98.905% for the three different kinds of tablets with amonafide, and 100.73, 101.54% for the two types of tablets with mitonafide) and selective, even when degradation products are present. The volume of extractor liquid must be specially taken into account with regard to the accuracy of the method, because drug extraction can be influenced by the nature of the excipients.
开发并验证了一种用于定性和定量测定氨萘非特（CAS 69408-81-7）和米托萘非特（CAS 54824-17-8）这两种新型抗肿瘤分子的高效液相色谱（HPLC）方法，用于成品药物剂型（片剂）。这项工作提交的结果表明，HPLC方法具有线性（氨萘非特的线性范围为0.54微克至2.70微克，米托萘非特的线性范围为1.40微克至5.25微克）、灵敏（氨萘非特的鉴别能力为0.1098微克，米托萘非特的鉴别能力为0.1324微克）、精密（氨萘非特片剂的批内变异系数≤2.39%，批间变异系数≤1.18%；米托萘非特片剂的批内变异系数≤1.38%，批间变异系数≤0.96%）、准确（含氨萘非特的三种不同片剂的平均回收率分别为97.55%、98.85%、98.905%；含米托萘非特的两种片剂的平均回收率分别为100.73%、101.54%）且具有选择性，即使存在降解产物时也是如此。就该方法的准确性而言，必须特别考虑提取液的体积，因为药物提取会受到辅料性质的影响。
