Robust, Sensitive and Validated RP-HPLC Modus Operandi for the Quantitation of Fixed Dose Combination of Gatifloxacin and Flurbiprofen
Author(s): K. Shankar*, M. Ramayyappa and G. Raveendra Babu
Abstract
In this study, we aim to create a technique for the simultaneous determination of stability indicators of Gatifloxacin (GTF) and Flurbiprofen sodium (FLU) using reversed phase high performance liquid chromatography in ophthalmic dosage form that is easy to perform and replicate with high reliability. For the RP-HPLC analysis, a thermosil C18 column (4.6 x 250 mm, 5 μm) is used with a mobile phase comprising of 0.02 M phosphate buffer: acetonitrile (70:30) at a velocity of 1.0 ml/min. The 236 nm wavelength was used for the detection. GTF and FLU were shown to have retention durations of 2.152 min and 7.881 min, respectively. It was determined that the linearity ranges for GTF and FLU were 20-60 μg/ml and 2-6 μg/ml, respectively. For marketed formulation, both GTF and FLU had recoveries of 98.73 and 99.21 percent, respectively. Results showed that the medications had correlation coefficients greater than 0.99. Acceptance was also achieved with respect to other aspects such as ruggedness, robustness, etc. The RP-HPLC methods for showing stability were found to be reliable, quick, exact, and easy to use. Using this simple technique, the selected medicaments in bulk and ophthalmic dose forms can be estimated simultaneously.
