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ISSN 2063-5346
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A NOVEL ANALYTICAL APPROACH FOR SIMULTANEOUS ESTIMATION OF LEVOFLOXACIN AND AMBROXOL HCL BY HPLC-DAD METHOD WITH DEGRADATION STUDIES

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Uttam Prasad Panigrahy[a]*, Satyabrata Bhanja[b], Nurjamal Hoque[c], Kumaraswamy Gandla[d]
» doi: 10.31838/ecb/2023.12. 4.134

Abstract

A simultaneous estimation of Levofloxacin and Ambroxol HCl by HPLC-DAD method with degradation studies was developed. It was carried out using Symmetry C8 (4.6 x 150mm, 5m, Make: XTerra) column with mobile phase consists Phosphate Buffer (6.2): Methanol: ACN [30:30:40, v/v/v] with flow rate 1mL/min at 244nm. Levofloxacin and Ambroxol HCl were eluted at 2.235 and 3.787mins respectively. Validation was performed as per ICH guidelines, which shows linearity 10-50 μg/mL of Levofloxacin and 1.5-7.5μg/mL of Ambroxol HCl with R2 was 0.999. Accuracy was obtained to be 99.24-101.6% for Levofloxacin and 98.20-99.84% for Ambroxol HCl respectively and precision which shows %RSD less than 2%. Stress studies were carried out which shows that Levofloxacin is maximum degraded in peroxide and alkaline degradation and moderately degraded in acidic and thermal degradation and Ambroxol HCl is maximum degraded in acidic, peroxide and thermal degradation and less degraded in alkaline degradation. This method was applicable for formulation development, routine analysis and stability of Levofloxacin and Ambroxol HCl.

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