STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CEFIXIME AND PARACETAMOL IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, accurate precise Stability indicating RP-HPLC method for the estimation of Cefixime and Paracetamol in pure and pharmaceutical dosage form has been reported. Quantitative estimation of Cefixime and Paracetamol was done by using WATERS HPLC 2965 SYSTEM with Auto Injector and PDA Detector on a BDS C18 column (250 mm x 4.6 mm, 5µ). A 10µL syringe was used for injecting the samples. Data was analyzed by using Empower 2 software. UV-VIS spectrophotometer shimadzu with special bandwidth of 2mm and 10mm and matched quartz was used for measuring absorbance for Cefixime and Paracetamol solutions. The mobile phase consists of a Buffer: Acetonitrile (60:40) And at a flow rate of 1 milliliter/minute. Cefixime and Paracetamol were eluted at approximately 7 minutes. The wavelength was found to be 260nm. A linear response was observed in the concentration ranges of 20-120µg/ml with a regression coefficient of 0.999. Forced degradation studies were performed on pure sample of Cefixime and Paracetamol using acid (0.1 Normal (N) hydrochloric acid), base (0.1 N sodium hydroxide), peroxide (30% H2O2) and thermal (105°C) conditions. The developed method was validated with respect to specificity, precision (% RSD about 0.4%), linearity (linearity of range about 20-120 µg/mL), robustness, LOD and LOQ values were found to be 0.255 and 0.047 respectively.