Evaluation of cefaclor oral suspensions stability using reversed phase high performance liquid chromatography and antimicrobial diffusion methods

ABSTRACT

The effect of temperature stresses on Cefaclor suspensions under different storage conditions for a duration of 14 days was tested. The degradation of Cefaclor was determined on the 2[nd], 7[th] and 14[th] day after reconstitution using a sensitive and precise Reversed phase High Performance Liquid Chromatographic [RP-HPLC] method. The RSD values for Forticef, Midocef, Ceclor, Cefabac and Cloracef, indicated a good precision of the RP-HPLC method. The limit of detection [LOD] and the limit of quantification [LOQ] were found 0.008 mg/ml and 0.03mg/ml respectively. The antimicrobial effect of Cefaclor suspension was also tested against pathogenic bacteria using the cylinder diffusion method. The RSD values range of the antimicrobial assay for all the Cefaclor compounds were 1.47-3.7%. The LOD and LOQ were 0.2mg/ml and Img/ml respectively. During the normal use of Ceclor, Midocef, and Forticef the loss of activity and the degradation were less than 5% on the 14[th] day of preservation at 4°C. However, the percentage of degradation for Cefabac and Cloracef on the 14th day reached 5 and 6%, respectively. Statistical multiple comparison between the effect of 4°C and 25°C indicated non significant mean differences [P >/= 0.05] for Forticef, Cefabac, Ceclor and Cloraf and significant effect for Midocef [P Ceclor. Multiple comparisons between days of storage showed non significant mean difference values at 4°C except Cefabac. However significant results between days were found at 25°C and 37°C except for Midocef between [7[th] and 14[th] day]. It was found that the pediatric suspensions of Cefaclor in the Jordanian market were stable and contained the amount of active ingredient specified by the United States pharmacopoeias specification [USP] and the British Pharmacopoeias specifications [BP]