Optimizing the analysis process for quantitative determination of cefaclor 250 mg in hard capsules using high performance liquid chromatography

Abstract

  The aim of study was to develop an accurate and sensitive method for quantitative determination of cefaclor 250 mg in hard capsules using ion-pair. Cefaclor is a zwitterion and the degree of ionization of cefaclor affects the retention of compound in the reversed phase chromatographic column by investigating the concentration of buffer solution at pH 2.5, pH 4.5 and pH 7.5. The experimental results optimized mobile phase composition at pH 2.5, with a flow rate 1.5 mL.min⁻¹ and samples were prepared with the volume of mobile phase was injected at 10 μL, the symmetrical shape chromatography was symmetrical with tailing resolution at 0.988. Chromatography parameters were stainless steel RP–18 column (250 mm × 4.6 mm i.d., 5 μm particle size), at 40 ℃. The determinations were performed using PDA detector at 265 nm. The method is validated for the specificity, linearity, and was applied successfully to determine the content of cefaclor in 250 mg hard capsules with recovery of 100.05 % and a relative standard deviation smaller than 2.0% (%RSD = 0.40). This proposed method is applicable for the determination of three pharmaceutical preparations of cefaclor in hard capsule drugs in the market. The results showed that all samples met the cefaclor content as prescribed by the Vietnamese Pharmacopoeia V.