Stability Indicating Rp-HPLC Method Development and Validation for the Estimation of Cefadroxil and Ambroxol in the Bulk and Synthetic Mixture

A simple, rapid, accurate, and precise stability-indicating RP-HPLC method was developed to simultaneously estimate Cefadroxil and Ambroxol HCl in the bulk and synthetic mixture.This method was developed using the Nuclosil C18 column (150mm x 4.6mm) with a mobile phase consisting of 0.01N sodium dihydrogen phosphate-acetonitrile (60:40v/v).The isosbestic point of Cefadroxil and Ambroxol HCl was identified at 244 nm.Linearity was observed in the concentration range of 62.5-375 µg/ml for Cefadroxil and 7.5-45.0µg/ml for Ambroxol HCl, with R 2 values of 0.998 and 0.999, respectively.The method was validated statistically and by recovery studies.The mean % recovery was found to be 98.74 % and 99.25 % for Cefadroxil and Ambroxol HCl respectively.Stability testing of Cefadroxil and Ambroxol HCl was carried out according to ICH guideline Q1A (R2).Cefadroxil and Ambroxol HCl were subjected to various stress conditions including acidic, alkaline, oxidation, thermal, and UV decomposition.Significant degradation was observed under acidic, alkaline, oxidative, thermal, and UV conditions.Among the degradation pathways, oxidative degradation occurred at a faster rate compared to other degradation processes.