European Journal of Biomedical and Pharmaceutical Sciences

STABILITY STUDY FOR THREE BRANDS CO-AMOXICLAV ORAL SUSPENSION (312.5/5ML) AFTER RECONSTITUTION AT REFRIGERATOR (2-8OC)

Abdulkarim Kassem Alzomor*, Nahlah Mansour Noman and Sam Abdullah Alfarzai

ABSTRACT

Oral suspensions of antibiotics are mainly available as dry powders for reconstitution. Many reconstituted antibiotic suspensions are to be kept refrigerated in order to get the optimal benefits from the drug. However, many patients cannot keep to the specified storage conditions for different reasons like no refrigerator and irregular power supply that may result in various degrees of degradation of the product. The absence of quality analysis by the national drug regulatory authority for drugs that are manufactured in Yemeni Companies and for drugs imported and the absence of health education about the correct method for storage and use of drug according to the specifications that ensure the drug maintains its therapeutic effect during the period of use. All of these enforce us to do stability study for one of the most common used antibiotics (amoxicillin-clavulanate potassium) as oral suspension for two brands compare with reference brand (the original) when stored at refrigerator (2-8OC) after reconstitution. Assay test was done for three different batches of each brand according to pharmacopeial tests at period time 10 days start from zero time using HPLC and the main results for original brand (Augmentin) was within the limits (90%-120% for amoxicillin and 90%-125% for clavulanic acid). The imported brand (Augmenta) was within the limit for amoxicillin (96%-107.8%) along the recommended period and the clavulanic acid for two days only within the limit (93%-103%) and after that the concentration of clavulanic acid reduced in two batches and were out of the limit (82%-86%). Whereas the results of assay for local brand (clavimox) was within the limit (99%-121%) for amoxicillin and clavulanic acid (95.6%-120%) along the period was recommended in company leaflet.

Keywords: co-amoxiclav, degradation, reconstitution, stability, suspension.