Analytical Method Development and Validation for the Simultaneous Estimation of Cefuroxime and Linezolid by RP-HPLC

Dr. Gampa Vijay Kumar^1*, Dr. D. Naresh², N. Swathi^3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara,  Rangareddy, Telangana, India.
²KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana,India.
³KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana,India.

A B S T R A C T
A newmethodwas establishedfor simultaneous estimation of Cefuroxime and Linezolid by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Cefuroxime and Linezolid by using Agilent C185µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer pH 4.0: ACN  (30:70%v/v), detection wave length was 254nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software-LC-20 Solution. The retention times were found to be 3.503 mins and 2.577mins. The % purity of Cefuroxime and Linezolid was found to be 100.3% and 101.1%respectively. The system suitability parameters for Cefuroxime and Linezolid such as theoretical plates and tailing factor were found to be 1.3, 5824.4 and1.2,2936.0 the resolution was found to be 9.4. The analytical method was validated according to ICH guidelines (ICH, Q2(R1)). The linearity study for Cefuroxime and Linezolid was found  in  concentration  range   of  20μg-100μg  and  20μg-100μg   and correlation coefficient (r2) was found to be 0.999 and 0.999,% mean recovery was found to be 102.5% and 101.0%, %RSD for repeatability was 0.6 and 0.5, %RSD for intermediate precision was 0.7and 0.6 respectively. The precision study was precise, robust, and repeatable. LOD value was 3.1 and 3.02 and LOQ value was 10.1 and 10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Cefuroxime and Linezolid in API and Pharmaceutical dosage form.
Keywords: Agilent C18, Cefuroxime and Linezolid, RP-HPLC