DEVELOPMENT AND VALIDATION OF NEW RP- HPLC METHOD FOR THE QUANTIFICATION OF DEGRADATION IMPURITIES IN LEVOFLOXACIN TABLET DOSAGE FORM
A HPLC method was developed and validated to determine impurities in Levofloxacin in its formulation. Separation of Levofloxacin from unknown degradation products was achieved on Xterra RP18 (250mmx4.6mm) 5μm using gradient elution. Five impurities have been separated - Levofloxacin related compounds 1,2,3,4,5 but according to I.P, only Piperazine analogue is known impurity which is validated here. The method is observed stability indicating by performing stressed study in various conditions such as acid, alkali, oxidation, heat & radiation. The peak purity of Levofloxacin peak at every degradation sample shows that the Levofloxacin peak is homogenous and there are no co-eluting peaks indicating that the method is stability indicating and specific. The method was fully validated in line with pharmacopoeial and ICH guidelines. In addition, solution stability, filter variability, precision, linearity and method robustness were also evaluated to meet analytical challenges. The method was validated for accuracy from LOQ to 150% of actual standard concentration. This stability indicating related substances method can be successfully imparted for quality control purpose.