Rs-Method Development of Cefuroxime Acid for Impurities by Hplc

Abstract

HPLC method has been developed for determination of Cefuroxime Acid  with its related substances in alaboratory mixture By performing several hidden trials in the laboratory finally a selective, sensitive,robust and accurate method was developed with the following chromatographic set up Column Betasil C1(250*4.6mm,5µ) mobile phase Methanol: Buffer (50:50v/v), flow rate 1.0 ml/min Sample cooler temp 10°C±1.0°C,Column oven Temp. 30°C±1°C,Injection volume 10 µl and eluent was monitored at 278 nm.. After the method is finalised it was validated and it was found to be accurate and precise. The proposed HPLC method developed is found to be selective,sensitive,robust and accurate for the quantification of Cefuroxime acid. The method is capable of detecting lower limit of quantification to even 10ng.Hence the method is found to be suitable and selective for the Related substance method it helps to quantification all impurities. Linearity, regression value, recovey, % RSD of method precision, LOD and LOQ values were found with in the limits. In this method impurities were well seperated from the main peak. This method was found to be satisfactory. Limits for reporting threshold and total impurities were 0.1% and 2.0%, respectively, as per Q3B(R) Impurities in New drug Products.