Development of HPLC-UV Method for analysis of cefixime in raw materials and in capsule

Abstract EN

A simple, selective and rapid reversed phase High Performance Liquid Chromatographic (HPLC) Method for the analysis of cefixime in bulk material and capsule has been developed and validated.

The chromatographic system consisted of a LC-10 AT VP pump, SPD-10 AVP UV/visible detector.

The Separation was achieved from Bondapak C18 column at ambient temperature with a mobile phase consisting of methanol: buffer solution (sodium dihydrogen phosphate) [35: 65 v/v, pH=2.75 adjusted with phosphoric acid] at a flow rate of 1ml/min and the retention time was about 6 minutes.

The method is selective to cefixime and able to resolve the drug peak from formulation excipients.

The system suitability with retention time was (Mean + %CV) 5.819 + 0.51.The calibration curve was linear over the concentration range of 0.039-20μg/ml (r2 = 0.9998).

The proposed method is accurate and precise (Intra day and Inter day variation, RSD were 0.53-1.64) and linear within the desired range.

The LOD and LOQ was detected as 0.0195μg/ml and 0.039μg/ml respectively with r2 = 0.9996.

The accuracy result of seventy percent drug (70%) was 99.82%, hundred percent (100%) was 99.89%, and one thirty percent (130%) was 100.12%.

Therefore, this method could be used as a more convenient and efficient option for the analysis of cefixime in raw material and capsule dosage form.