Analytical Method Development and Validation of Mupirocin and Bromelain in API and Its Dosage Form by RP-HPLC

Abstract

A new method was established for simultaneous estimation of Mupirocin and Bromelain by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Mupirocin and Bromelain by using Inertsil ODS C18 5µm (4.6*250mm), flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v)   (pH was adjusted   with   orthophosphoric   acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Mupirocin and Bromelain was found   in   concentration   range of 1μg-5μg and 100μg-500μg   and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was0.7 and 0.4, % RSD for intermediate precision was 0.18 and 0.39 respectively.