Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF ANTIBIOTIC DRUG IN PHARMACEUTICAL DOSAGE FORM

*Diksha R. Bais

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Abstract

Numerous infections are treated with Antibiotics. Moxifloxacin is utilized in numerous therapeutic procedures. A method involving an HPLC-diode array detector (DAD) was developed and proven for measuring moxifloxacin in pharmaceutical dose form. A simple, specific, and precise stability indicating reverse phase high performance liquid chromatography method was developed and validated as per the ICH guidelines for the simultaneous determination of Moxifloxacin and Prednisolone in bulk and combined dosage forms. The quantification was carried out by using hypersil BDS C18 (250mm*4.6mm, 5μ) column at ambient temperature with orthophosphoric Buffer pH 4 Acetonitrile: water (H2O):Trifluro acetic acid in ratio of 45:55:0.2% V/V as mobile phase. The flow rate is 1 mL /min and the estimation was carried out by using PDA detector at 254 nm. The retention time of MFX and PDS were 3.20 and 4.73 minutes respectively. The linearity was observed from 25.10-275.3 μg /mL with correlation coefficient 0.9998 for Moxifloxacin and 30.06-90.18 μg/mL with correlation coefficient 0.9964 for Prednisolone. The LOD and LOQ of Moxifloxacin and Prednisolone were found to be 23.09 & 33.93μg/mL and 0.998 & 0.9964 μg/mL respectively and the Statistics data for the MFX and PDS were concluded that the method was found to be simple, reliable, selective, reproducible and accurate. The method was successfully used for quality control analysis of Moxifloxacin and Prednisolone.

Keywords: Moxifloxacin (MFX), Prednisolone (PDS), RP-HPLC, Stability, and validation.