1Department of Quality Assurance Techniques, MET's Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, 422 003, Maharashtra State, India
2Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, 422 003, Maharashtra State, India
*Corresponding Author E-mail: sandeeps_iop@bkc.met.edu
Online published on 17 October, 2017.
A simple, rapid and accurate RP-HPLC method was developed and validated for the estimation of cefuroxime axetil in spiked human plasma using liquid-liquid extraction. Sufficient recovery was obtained when drug and internal standard (Guaifensin) were extracted using ethyl acetate with 1% formic acid. The chromatographic separation was performed on C18 (250 × 4.6 mm, 5 μm) column with mobile phase consisting of Potassium dihydrogenortho phosphate: methanol (60: 40% v/v). The flow rate was kept constant at 1 mL/min and detection was carried out at 276 nm. The calibration curve was found linear in the range of 1000-32000 ng/mL To minimize the heteroscedasticity, weighted calibration models were used with different weighing factors. The method was validated as per the US-FDA guidelines.
Cefuroxime axetil, weighted regression, RP-HPLC, Spiked human plasma, Bioanalytical Method Validation
