Rajkiran Kolakota*, Y. Rupavathi
Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P
A HPLC method was developed and validated to determine trace amounts of levofloxacin related substances & degradation products in its formulation. Separation of levofloxacin from impurity A, impurity B, impurity C and unknown degradation products was achieved on a YMC-Pack Pro C18 (50×4.6 mm; 3.0µm) using isocratic elution with Buffer, Methanol and Acetonitrile in the ratio of 7.7:1.3:1.0. The method is observed stability indicating by performing stressed study in various conditions such as acid, alkali, oxidation, heat & radiation etc. The degradation pattern showed the nature that levofloxacin is highly degradable in acid & oxidation stress while much stable toward basic hydrolysis. The method was fully validated in line with pharmacopoeial and ICH guideline. The method was validated for accuracy from LOQ to 150% of actual standard concentration. Linearity was established including LOQ, 0.29µg/mL, 0.20µg/mL, 0.13µg/mL, 0.18 µg/mL for levofloxacin, impurity-A, B, C and D respectively. This stability indicating related substances method can be successfully imparted for quality control purpose.
Keywords: levofloxacin, HPLC, related substances, degradation, validation