ANALYTICAL METHOD DEVELOPMENT AND VALIATION FOR CEFIXIME FROM HARD CAPSULES 100 MG BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)

Abstract

This research project aims to construct and determine the Cefĩxime from hard capsules 100 mg by high performance liquid chromatography (HPLC) according to USP 34. The chromatography was performed on a HiQ Sil C18HS 4,6 mm I.D x 100 mm L column, PDA detector at 254 nm. The isocratic elution with flow rate of 1.1 mL/min, mobile phase composition of acetonitrile: tetrabutylammonium hydroxide (1:3). The sample was dissolved in phosphate buffer pH 7.0. The linearity of cefixime were found in the range of 0,04-0,4 mg/mL. The limit of detection and the limit of quantitation were 0,003 mg/mL and 0,01 mg/mL, respectively. The accuracy of the proposed method was determined by recovery studies and ranged from 99.72 to 101.25%. The precision with repeatability %RSD = 0.062% and intermediate precision %RSD = 0.063% was achieved by two technicians. All the validation parameters were within the range. The method was validated for specificity, linearity, accuracy, precision, limit of detection and limit of quantitation. This proposed method is applicable for the determination of the cefixime in pharmaceutical formulations