DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHIC METHOD FOR GATIFLOXACIN AND KETOROLAC TROMETHAMINE IN COMBINED DOSAGE FORM

Abstract

A fast, sensitive, and accurate stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for simultaneous determination of gatifloxacin and ketorolac tromethamine in combined dosage form. Chromatographic separations were achieved on BDS Hypersil C₈ column (250 × 4.6 mm) with mobile phase that consisted of methanol and phosphate buffer (pH 3.0) in the ratio of (55:45 v/v) at a flow rate of 1.5 m Lmin⁻¹. The analytes were detected at 270 nm using ultraviolet detection. The retention times of gatifloxacin and ketorolac tromethamine were found to be 2.460 and 6.366 min, respectively. When forced degradation studies were applied to both the drugs in combination, it was found that both gatifloxacin and ketorolac tromethamine were very stable under the basic, acidic, wet heat and oxidative environment. The method was linear in the concentration range of 30–90 µg mL⁻¹ for gatifloxacin and 50–110 µg mL⁻¹ for ketorolac tromethamine. The correlation coefficients were found to be 0.9998 and 0.9999 for gatifloxacin and ketorolac tromethamine, respectively. The method resulted in good separation of both the analytes with acceptable tailing and resolution. The developed method can be used for routine determination of gatifloxacin and ketorolac tromethamine in commercial formulations.

Keywords:

• forced degradation studies
• gatifloxacin
• HPLC
• ketorolac tromethamine

Notes

n = Average of 5 analyses.

n = Average of 5 analyses.

n = Average of 3 determinations.

n = Average of 10 determinations.