de Oliveira Antonia Maria Cavalcanti, Löwen Teresa Cristina Raposo, Cabral Lúcio Mendes, dos Santos Elizabeth Moreira, Rodrigues Carlos Rangel, Castro Helena C, dos Santos Tereza Cristina
Instituto Vital Brazil, Niteroi, RJ 24310-110, Brazil.
J Pharm Biomed Anal. 2005 Jul 15;38(4):751-6. doi: 10.1016/j.jpba.2005.02.004.
A simple, rapid, sensitive and specific reversed-phase high performance liquid chromatographic method involving ultraviolet detection (HPLC-UV) was developed for analysis of didanosine in drug substance and formulated products, tablets. Chromatography was carried out on a pre-packed, Lichrospher 100 Rp-8 (5.0 microm, 250 mm x 4.0 mm) column using 0.01 M sodium acetate solution:methanol (85:15, v/v) adjusted to pH 6.5 with acetic acid as mobile phase at a flow rate of 1.5 ml/min and a 248 nm detection. Hypoxantine was confirmed as the main degradation product. The assay was linear over the concentration range of 50-150 microg/ml (R approximately 0.999). The method was validated for accuracy and precision.
建立了一种简单、快速、灵敏且特异的反相高效液相色谱法（HPLC-UV），用于原料药及制剂（片剂）中去羟肌苷的分析。色谱分析在预填充的Lichrospher 100 Rp-8（5.0微米，250毫米×4.0毫米）柱上进行，以0.01 M醋酸钠溶液：甲醇（85:15，v/v）为流动相，用醋酸调节pH至6.5，流速为1.5 ml/min，检测波长为248 nm。次黄嘌呤被确认为主要降解产物。该测定法在50-150微克/毫升的浓度范围内呈线性（R约为0.999）。该方法的准确性和精密度经过了验证。
