A new analytical method development and validation for estimation of cefp odoxime, azithromycin in bulk and tablet by rp-hplc

Abstract

Analytical Method Development and Validation for Azithromycin and Cefpodoxime in bulk and Combine Dosage Form by RP-HPLC, New method was established for simultaneous estimation of Azithromycin and Cefpodoxime by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Azithromycin and Cefpodoxime by using Symmetry ODS C18 (4.6mm×250mm, 5µm) particle size, flow rate was 1.0 ml/min, mobile phase ratio was (70:30 v/v). The system suitability parameters for Azithromycin and Cefpodoxime such as theoretical plates and tailing factor were found to be 5387, 0.97 and 5398 and 1.26, the resolution was found to be 2.97. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Azithromycin and Cefpodoxime was found in concentration range of 30µg-70µg and 60µg-140µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.14% and 100.56%, %RSD for repeatability was 0.1 and 0.5, % RSD for intermediate precision was 0.1 and 0.1 respectively. The precision study was precise, robust, and repeatable. LOD value was 0.56 and 1.2, and LOQ value was 1.7 and 3.6 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Azithromycin and Cefpodoxime in API and Pharmaceutical dosage form.