Thursday , 29 February 2024

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Levofloxacin Andambroxol Hydrochloride in Bulk and Pharmaceutical Dosage Form

Dr. Hareesh Dara*, Dr. Ampati Srinivas, D Siva Dinesh, Meesa Rajendar
St John College of Pharmcy, Hasanparthy, Hanamkonda, Telangana.

A new, precise, rapid, accurate RP-HPLC method was developed for the Simultaneous Estimation of Levofloxacin and Ambroxol HCl in pharmaceutical dosage forms. After optimization the good chromatographic separation was achieved by Isocratic mode with a Mixed phosphate buffer: ACN: methanol (40:40:20v/v%) the mobile phase with Inertsil ODS C18-250X4.6mm, 5µ,column as stationary phase at flow rate of 1 mL/min and detection wavelength of 223nm.The retention times for Levofloxacin and Ambroxol HCl found to be 2.737min and 4.793min respectively. The linearity of this method was found in the concentration range of 60 µg/mL to 140 µg/mL for Levofloxacin and 9-21 (μg/mL)for Ambroxol HCl. The correlation coefficient R2value is found to be0.997 for Levofloxacin and 0.995 for Ambroxol HCl. The LOD and LOQ for Levofloxacin were found to be 2.66 mcg µg/mL and 15.69 µg/mL respectively. The LOD and LOQ for AmbroxolHCl were found to be 8.05 µg/mL and 47.55µg/mL respectively. This method was found to be good percentage recovery for Levofloxacin AndAmbroxol HCl were found to be 101.28 and 99.32 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage form. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, specificity and Robustness.

Keywords: UV spectrophotometer, Levofloxacin and Ambroxol HCl, High performance liquid chromatography.

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