Journal of Harmonized Research in Pharmacy

FORMULATION & ANALYSIS OF LEVOFLOXACIN HEMIHYDRATE BY RP-HPLC IN BULK & TABLET DOSAGE FORM

Abstract

Author(s): Dey Bivha, Mahapatra Sujata, Tiwari Prabhakar

Abstract Objective(s) Developed and validate analytical method for quantitative determination of Levofloxacin tablet formulation. It was prepared by wet granulation method and evaluated by various p hysicochemical parameters. Analytical method was validating in different parameters like specificity, accuracy, linearity, precision, range, detection limit, robustness. Study in reversed phase high performance liquid chromatographic (RP-HPLC) method for the quantitative determination of Levofloxacin in bulk tablet and finished tablet. Materials and Methods: A shim-pack CLC-ODS column(25cm X 4.6mm, 5µm) and a mobile phase constituted of Buffer (850 ml of 0.05 (M) Citric acid monohydrate and 10 ml of 1 (M) ammonium acetate) :Acetonitirile (150) were used. The flow rate was 1 ml/min and the analyses performed using ultraviolet (UV) detector at a wavelength of 293 nm using levofloxacin Pure drug as an internal standard. Separation was completed within 15 to 17 min. Results: The developed method showed good resolution between formulated tablet and standard drug. The standard solution of Levofloxacin was prepared to obtain the concentration of about 100 ?g /mL, Six (6) replicate injection of homogeneous sample, their % RSD was 0.07 % & test solution was 0.17 %. The assay of Levofloxacin Tablet Obtained by Different Chemist, Date & Column 97.56 %, 98.69 % & 98.24 % respectively. The assay of different flow rate and temperature was 98.07% and 98.12% respectively. The prepared tablet was studied for its stability test for 24 hrs at preselected time interval like initial, 4 hrs, 8 hrs,12 hrs and 24 hours. Their assay % result was obtained 98.62, 98.54, 97.60, 98.50 and 98.41 % respectively. Conclusion: The method is linear, quantitative, reproducible and could be used as a more convenient, efficient and economical method for the trace analysis of drug in raw material and tablets. Keywords: Antibiotics, Fluoroquinolone, High Performance Liquid Chromatography, Levofloxacin, Quantitative analysis, Validation studies.