维A胺酸的质量研究  

STUDY ON THE QUALITY OF RETINAMIDIC ACID

作　　者：王琰[1] 刘玉玲[1] 王慕邹[1] 

机构地区：[1]中国医学科学院

出　　处：《药学学报》2000年第9期688-691,共4页Acta Pharmaceutica Sinica

摘　　要：目的　研究维A胺酸质量控制方法。方法　用反相高效液相色谱法和正相高效液相色谱法。结果　反相色谱法中维A胺酸在 0 0 5～ 0 5 μg·μL-1与峰面积呈良好线性关系 ,检出限为 3ng ;正相色谱法中 ,维A酸的检出限为 5ng ;并用两种方法同时检测了 3批维A胺酸样品。 结论　维A胺酸及其异构体分离良好 ,样品中未检出维A酸和对氨基苯甲酸。反相色谱法简便、准确、重现性好 ,适用于维A胺酸及其杂质的质量控制 ;正相色谱法对维A胺酸、维A酸和对氨基苯甲酸分离较好 。AIM To determine retinamidic acid and its isomer by reversed phase HPLC and to control the remains of reactants, tretinoin and p aminobenzoic acid, in retinomidic acid by normal phase HPLC. METHODS A reversed phase HPLC system consisting of an ODS column and a mixture of methanol 0 02 mol·L -1 sodium dihydrogen phosphate solution ( 82∶18 ) as the mobile phase was used. The flow rate was 1 0 mL·min -1 and detection was effected at 367 nm. A normal phase HPLC system including a CN column and a mixture of n hexane alcohol glacial acetic acid (100∶10∶0 3) as the mobile phase was used. The flow rate was 0 8 mL·min -1 and the wavelength of detection was 320 nm. RESULTS The assay of retinamidic acid displayed good linearity over the concentration range of 0 05～0 5 μg·μL -1 and the limit of detection was 3 ng in the reversed phase HPLC. The detecting limit of tretinoin was 5 ng with normal phase HPLC. Three lots of retinamidic acid samples were analyzed with the two HPLC methods. CONCLUSION Retinamidic acid and its isomers were separated perfectly. Tretinoin and p aminobenzoic acid were not detected in the samples. The reversed phase HPLC is simple, accurate and reproducible. It can be used to control the quality of retinamidic acid and its isomers. The normal phase HPLC is better in separating tretinoin and p aminobenzoic acid and may be used to control the impurity of reactants.

关 键 词：维A胺酸 质量控制 高效液相色谱 

分 类 号：R979.19[医药卫生—药品] R927.11[医药卫生—药学]