QUALITY EVALUATION OF PHARMACEUTICAL HUMAN SERUM ALBUMIN PREPARATIONS AVAILABLE IN PHARMACIES IN ADEN GOVERNORATE - YEMEN

Human serum albumin(HAS) is important for the body, as it performs a set of functions such maintaining osmotic pressure inside cells, transporting drugs and ions, others. The fraudulent process preparations may lead to deterioration patient's health condition sometimes death. In current study, two types albumin that were not authorized by Yemeni ministry entered country through smuggling studied. results study proved these exposed high temperatures, so denaturation HSA, in addition oxidation substance N-acetyl-tryptophan. reverse phase (RP) high-performance liquid chromatography (HPLC) method assess gradient elution (a combination acetonitrile/water, supplemented with 0.1% (v/v) trifluoroacetic acid) was used separate samples on C4 (n-butyl-coated silica) column. Two main peaks observed at 4.970 10.850 min, representing stabilizer N-acetyl-tryptophan (N-Ac-Trp) HSA respectively. Validation demonstrated can be determined an accurate precise manner, range between 0.1 5g/ml, without interference matrix ingredients. limit detection (LOD) lower quantification (LLOQ) values 0.23 0.72 g /ml, do meet quality specifications World Health Organization, exposure temperatures bad storage leading oxidation. analysis all less than permissible because each sample must contain 10 grams per 50 ml.