Development and validation of a novel stability indicating RP-HPLC method for the quantitative determination of marbofloxacin in its tablets

ABSTRACT

A fast, feasible, isocratic, stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method has been developed and validated for the quantitative determination of marbofloxacin in marbofloxacin tablets. The method was developed using Zorbax SB C18 (150 mm × 4.6 mm), 5-µm column thermostated at 30°C, mobile phase A (1 mL of trifluoroacetic acid in 1000 mL of water), mobile phase B (acetonitrile) in the ratio of 83:17 v/v at flow rate of 1.0 mL/min, and an injection volume of 10 µL. The analyte was monitored at a wavelength of 298 nm. The method was validated in accordance with the Food and Drug Administration (FDA) Veterinary International Conference on Harmonization guidelines. To demonstrate stability indicating ability of method, drug product was subjected to the stress condition of acidic, basic, humidity, thermal, oxidative, and photolytic degradation.

GRAPHICAL ABSTRACT

KEYWORDS:

• Development and validation
• HPLC–UV
• marbofloxacin tablets
• stability indicating
• VICH

Acknowledgment

The authors are grateful to the management of Jubilant Generics Limited, Noida for providing amenities to perform this work.