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 2nd, 7th and 14th 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 RPHPLC 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 1mg/ml respectively. During the normal use of Ceclor, Midocef, and Forticef the loss of activity and the degradation were less than 5% on the 14th day of preservation at 4o 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 4o C and 25oC indicated non significant mean differences (P≥0.05) for Forticef, Cefabac, Ceclor and Cloraf and significant effect for Midocef (P ≤ 0.05). Significant effects were observed between (4o C and 37oC) and (25o C and 37o C) for all except Ceclor. Multiple comparisons between days of storage showed non significant mean difference values at 4o C except Cefabac. However significant results between days were found at 25o C and 37o C except for Midocef between (7th and 14th 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).