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

Abstract

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