Original Article - (2014) Volume 3, Issue 2
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.