Investigation of the Chemical Stability of Reconstituted Cefadroxil Oral Suspension Using Two Type of Water at Different Storage Conditions in Aden, Yemen

Abstract

Cefadroxil   for pediatric use comes in the form of an oral powder,   which has to be reconstituted before administration. Concerns have been raised about home storage conditions and the appropriateness of the temperature of the water used to reconstitute oral powders such as Cefadroxil into suspensions, within the recommended shelf life during the period of use, in-use stability refers to products in multi-dose containers that are at risk of losing their contents because of repetitive opening and closure. To investigate the effect of temperature on Cefadroxil oral suspension (250 mg/5ml) reconstituted in water at different temperature storage conditions. The Method was performed by using (HPLC): JASCO, model LC-Net II/ADC,   C18 (250 mm × 4.6 mm i.d.) Column MS-II, with an isocratic mobile phase of Acetonitrile and Phosphate buffer pH 5.0 (4:96) with run time 15 minutes, the determinations were performed at a flow rate of 2.0 ml/min, and UV detector set at 230 nm. this study was carried out by selection of two brands of Cefadroxil dry suspension) imported and local brands),    exposed to different conditions (refrigerator conditions (2-8°c) and ambient temperature (at room temperature 25 – 29°c) after reconstitution by two waters (boiled water and distilled water) then the assay test was performed using HPLC for fourteen days 0 day, 3rd, 7th, 10th and 14th day. HPLC results showed a decrease in Cefadroxil concentration in samples prepared by heated water as compared to those prepared by cooled water at 25ᵒC. The statistical analysis result of the one way ANOVA test revealed that there was a significant difference (P<0.05) in the drug content of the Cefadroxil  brands evaluated in the study, because  Cefadroxil from the 0 day was higher than the limit in pharmacopeia (90-120%). There was a significant difference (P<0.05) in the drug content of the Cefadroxil  stored under various in-home storage conditions refrigerator 2 – 8°c and room temperature 25 – 29°c evaluated in the study. Reconstituted oral Cefadroxil suspension is stable at temperatures between 2 and 29℃ for a period of 3 days; reconstituted with distilled water also showed stability until the 7th day. This is seen in the concentrations of samples A and B. As a result of statistical comparison, the concentrations of Cefadroxil in a reconstituted oral suspension which were kept under different storage conditions were found to be statistically different at 0 to 14 days. It was concluded that after the preparation of the Cefadroxil reconstituted oral suspension, the storage conditions at different temperatures did cause degradation of the active compound.