Comparison of HPLC and UV Spectrophotometric Methods for the Determination of Cefaclor monohydrate in Pharmaceutical Dosages

This paper describes the development and evaluation of a HPLC and UV spectrophotometric methods to quantify Cefaclor Monohydrate in Oral suspensions and Capsules. HPLC analysis were carried out using a C18 Knauer column and a mobile phase composed of Triethylamine: methanol: Acetonitrile: water (2: 10: 20: 68)v\v%, with a flow rate of 1.0 mL/min and UV detection at 265 nm. For the spectrophotometric analysis, water was used as solvent and the wavelength of 264 nm was selected for the detection. Both methods were found to quantify Cefaclor monohydrate in Oral suspensions and Capsules accurately. Therefore HPLC and UV methods presented the most reliable results for the analyses of Oral suspension and Capsules. Introduction Cefaclor monhydrate (CAS 56238-63-2) (Figure 1) is a second generation cephalosporin with high antibacterial activity; it has enhanced in vitro activity against clinically important Grampositive and Gram-negative microorganisms (1). The chemistry of cephalosporins has been widely explored because of their extensive medical applications (2). Several analytical procedures are available in literature for the analysis of antimicrobial. These methods are spectrophotometry (3–13), high performance liquid chromatography (14–19), capillary electrophoresis (20), fluorimetry (21–24), polarography (25–29),titrimetry (30), and bioassay (31–32). Spectrophotometric assay for determination of other cephalosporins as ceftazidime has been described (33) but no method for Cefaclor monohydrate had been previously described. The purpose of this study was to develop and validate analytical methods to quantify Cefaclor monohydrate in Capsules & Oral suspensions, using HPLC and UV spectrometry. The results obtained by these methods were statistically compared, by using analysis of variance (ANOVA). In addition, the reliability and feasibility of them were evaluated focusing on routine quality control analysis. Figure 1. Structure of Cefaclor monohydrate