Thursday , 29 February 2024

Analytical Method Development and Validation by RP-HPLC for Simultaneous Estimation of Moxifloxacin and Prednisolone in Bulk Drug and Pharmaceutical Dosage

K. Kalyani2, P. Sowjanya3, Dr. T. Rajesh4, Dr. Gampa Vijaya Kumar*1
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy.
2,3,4Deapartment of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy.

A simple, specific, and fast stability indicating reverse phase liquid chromatographic method was established for instantaneous determination of Moxifloxacin and prednisolone in bulk drugs and pharmaceutical formulations. For the mobile phase, the first variable to be decided is whether an organic or aqueous eluent should be used. With the RP-HPLC analysis, either an aqueous eluent or a very polar organic solvent such as methanol or acetonitrile should be fixed. If the K’ values are too large with an aqueous solvent, organic solvent should be tried. If the K’ value are too low with organic solvent the separation should be attempted using a mixture of   two solvents with various properties. Optimum chromatographic separations among the Moxifloxacin, prednisolone and stress-induced degradation products were achieved within 10 minutes by use of BDS Hypersil C18 column (250 X 4.6 mm, 5 μm) as stationary phase with mobile phase Methanol HPLC Grade, Acetonitrile HPLC Grade. Detection was performed at 248 nm using diode array detector. The method was validated in accordance with ICH guidelines. Response was a linear function of concentrations over the range of 20–80 μg mL-1 for Moxifloxacin (r2 ≥ 0.998) and 40–160 μg mL-1 for prednisolone (r2 ≥ 0.998). The method was resulted in good separation of both the analytes and degradation products with acceptable tailing and resolution. The peak purity index for both the analytes after all types of stress conditions was ≥ 0.9999 indicated a complete separation of both the analyte peaks from degradation products. The method can therefore, be regarded as stability indicating.
Keywords: Reverse phase liquid chromatography, moxifloxacin, prednisoloneacetate, Degradation products, ICH guidelines

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